Toripalimab combined with chemotherapy in the treatment of primary tracheal squamous cell carcinoma: a phase II proof-of-concept study

Introduction

Primary tracheal tumors are uncommon, and 90% of them are malignant, with squamous cell carcinoma (SCC) and adenoid cystic carcinoma constituting the majority (1). Complete surgical resection, as a definitive therapy, often contributes to a favorable prognosis for tracheal SCC (2,3). However, extensive tracheal resection is technically difficult due to the natural limitation of trachea, and would increase the risks of anastomotic complications including granulation, restenosis and dehiscence (4). Tracheal replacement has been sporadically reported for extensive tracheal neoplastic tumors, but it remains a highly challenging surgical procedure (5).

Immunotherapy with anti-programmed cell death-(ligand) 1 [PD-(L)1] has revolutionized treatment paradigms for locally-advanced non-small cell lung cancer (NSCLC), and achieved favorable outcomes in the neoadjuvant setting such as down-staging and increased rate of R0 resection, as reported by CheckMate 816 (nivolumab), KEYNOTE-671 (pembrolizumab), and Neotorch (toripalimab) (6-8). Furthermore, several studies attempted to offer this regimen to patients with initially-unresectable NSCLC, with the hope of converting their tumors to a resectable state (9,10). For tracheal carcinoma, only few case reports explored the effect of immunotherapy as a salvage option for refractory tracheal malignancies. Osho and Maller applied immunotherapy with PD-L1 antibodies in the treatment of recurrent tracheal SCC after exhaustion of conventional therapy, and both cases achieved a significant tumor regression and symptom relief (11,12). However, clear-cut evidence is not available to elucidate the role of immunotherapy in primary tracheal SCC.

Toripalimab, a humanized IgG4K monoclonal antibody against PD-1, has previously shown a good safety, tolerability, and efficacy in advanced melanoma, gastric or urologic cancers (13,14). In 2023, toripalimab plus chemotherapy was approved by the US Food and Drug Administration for the treatment of advanced nasopharyngeal carcinoma (15), and by the China National Medical Products Administration as a first-line treatment for metastatic nonsquamous NSCLC in China (16).

Therefore, we conducted a phase II trial and reported the interim results of toripalimab in combination with chemotherapy in patients with initially-unresectable locally-advanced tracheal SCC, aiming to investigate the safety and effectiveness. A post-hoc analysis was performed to explore any potential biomarkers for tumor response. We present this article in accordance with the TREND reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-0773/rc).

Methods

Study design and patient selection

This study was an investigator-initiated, single-center, single-arm, phase II trial (LungMate-011, ClinicalTrials.gov Identifier: NCT04716751), and was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of Shanghai Pulmonary Hospital (No. L20-448, Dec 2020). All patients provided written informed consent before enrollment, and patients had the right to withdraw from the study at any time and for any reason.

Eligible patients were: (I) 18 years of age or older, (II) clinical stage III or above tracheal tumor, (III) histologically confirmed as primary tracheal SCC, (IV) upfront surgery considered infeasible, (V) Eastern Cooperative Oncology Group performance status 0–1, and (VI) adequate organ function. Key exclusion criteria were: (I) previous treatment for tracheal SCC with any antitumor regimen, (II) concurrent additional malignancy or history of malignant tumor within 5 years, (III) active autoimmune or infectious diseases, (IV) symptomatic grade 3 or 4 interstitial lung disease. Each case must receive detailed discussion in a multidisciplinary forum, and full eligibility criteria are provided in Appendix 1.

Perioperative evaluation

Tumor’s location, extension of invasion, and the degree of tracheal obstruction were evaluated by thoracic/cervical computed tomography (CT) scan and bronchoscopy. The pathologic diagnosis was made from bronchoscopic biopsies. Since there is no generally accepted TNM classification for tracheal malignancies, this study used Bhattacharyya’s criteria to stage the tumor: stage I, T1N0; stage II, T2N0; stage III, T3N0; stage IV, T4N0 or any N1 disease (17).

Treatment procedure

All patients received a combination of toripalimab (240 mg), paclitaxel (200 mg/m², or gemcitabine 1,000 mg/m² on days 1 and 8 if allergic to paclitaxel), and carboplatin (area under the curve 5) on day 1 of each 21-day cycle for 4 cycles. After 2 cycles of immunochemotherapy, patients received thoracic/cervical CT scans and bronchoscopy to evaluate the effectiveness of the therapy. Further treatment was decided by multidisciplinary team, including either tracheal resection or continued immunochemotherapy and consolidation radiotherapy. Generally, tracheal SCC was considered resectable after immunochemotherapy if the length of tumor along the trachea was less than 4.0 cm, without neighboring organs invasion such as great vessels and esophagus, and absence of bulky and/or multiple lymph node metastases. The exact limit for tracheal resection should depend on the total tracheal length and surgeon’s expertise, since fibrotic scar tissue following immunochemotherapy could decrease the tracheal distensibility‌. If tracheal resection was considered, adjuvant treatment with the same regimen was given once the patients were deemed fully recovered from surgery. For inoperable patients, definitive immunochemotherapy was administrated, continued until the completion of 4 cycles, with consolidation radiotherapy (Figure 1).

Figure 1 Flow of patients in this study. *, adjuvant treatment with the same regimen up to 4 cycles. AUC, area under the curve; ECOG, Eastern Cooperative Oncology Group; MDT, multidisciplinary team; N, node; T, tumor.

Adverse events (AEs) were monitored until 90 days after the last dose of Toripalimab administration, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

For selected patients who had an airway obstruction and dyspnea, debridement was performed under bronchoscopy and airway self-expanding covered metallic stent was placed as necessary.

Radiological and pathologic evaluation

Radiological responses were evaluated after the completion of 4 cycles of immunochemotherapy (before surgery for operable patients) according to Response Evaluation Criteria for Solid Tumors version 1.1.

An immunohistochemical analysis for PD-L1 was performed on the pre-treatment biopsy samples. In the resected primary tumor, major pathological response (MPR) was defined as less than 10% of viable tumor cells, while pathological complete response (pCR) was defined as the absence of any viable tumor cells in both the resected primary tumor and lymph nodes.

Surgical procedure

Surgery was performed 4–6 weeks after the last cycle of immunochemotherapy for patients who were considered resectable. Tracheal segmental resection and end-to-end reconstruction were the main scheduled surgical types. Different tracheal release maneuvers could be used to decrease the anastomotic tension (18). No further length of airway would be resected if the remnant trachea was deemed to preclude safe reconstruction, even in the condition of positive airway margin.

The membranous trachea was anastomosed by an interrupted suture, and the cartilaginous part by either figure-of-8 suture or interrupted suture depending on the anastomotic tension. Thymic tissues were used to cover the anastomotic site. After operation, two chest tubes were placed nearby the tracheal anastomotic site for drainage, and were removed when drainage output was less than 50 mL/d without air leak. Surgical complications were monitored during the first 30 days after operation.

Follow up

Physical exam and thoracic/cervical CT were performed every 6 months in the first five years, and annually thereafter. Bronchoscopy was performed as clinically indicated.

Statistical analysis

The primary end points were radiological response and AE. The secondary outcomes included surgical conversion rate and disease-free survival. The exploratory analyses examined the predictors of radiologic responses.

Continuous variables were presented as mean ± standard deviation or median and interquartile range (IQR), and categorical variables were presented as frequency and respective percentage. The Kaplan-Meier method was used to calculate disease-free survival, which was defined the interval from the date of diagnosis until disease recurrence or death. All statistical analyses were performed using R version 4.2.2 statistical software.

Results

Characteristics of the patients

A total of 6 patients were enrolled, with a median age of 60.5 years (Table 1). The median length of tumor along the trachea was 48.8 (IQR, 42.5–53.3) mm by radiological evaluation, and tumors occupied 90% of the tracheal lumen in 3 patients and 40% of the tracheal lumen in 1 patient under bronchoscopic evaluation. Three patients were staged as T4 due to invasion of esophagus (n=2) and left innominate vein (n=1), and 4 patients had N1 diseases. PD-L1 expression showed 3, 1, and 2 patients in <1%, 1–49%, and ≥50% groups, respectively.

Two of 6 patients received 2 and 3 cycles of immunochemotherapy, respectively, and were considered candidate for operation. The remaining 4 patients continued a definitive immunochemotherapy with consolidation radiotherapy.

Safety assessment

Treatment-related adverse events (TRAEs) of any grade were recorded in 6 patients. Most AEs were classified as grade 1, including fatigue (all 6 patients, 100%), fever (1 out of 6, 16.7%), leukopenia (16.7%), hypokalemia (16.7%), and pruritus (16.7%). A grade 2 AE of hepatic dysfunction occurred in one patient (16.7%). No patients experienced serious AEs.

Effectiveness by radiologic assessment

After completion of 4 cycles of immunochemotherapy (before surgery for operable patients), 4 patients (66.7%) had a radiologic partial response (PR) and 2 patients (33.3%) had a radiologic complete response (CR). Clinical down-staging was observed in all 6 patients. Three patients with T4 were down-staged to T3 (n=2) and T2 (n=1), and all 4 patients with N1 disease were re-evaluated as N0 after treatment. The median diameter of tumor decreased to 31.6 (IQR, 7.6–36.1) mm (Figure 2).

Figure 2 Detailed information about down-stage of 6 patients. (A) T stage, (B) tumor diameter. T, tumor.

Perioperative outcomes and pathological findings

Two patients were considered operable after immunochemotherapy, corresponding to a surgical conversion rate of 33.3%. The median interval between the administration of the last cycle of immunochemotherapy and operation was 30.5 days (range, 21 to 40 days). One patient with CR received carinal-preserving tracheal segmental resection via median sternotomy. She achieved R0 resection, with the subsequent pathology indicating pCR. The other patient who achieved PR received tracheal long-segmental resection after infrahyoid and bilateral pericardial release via video-assisted thoracic surgery; however, microscopic incomplete resection (R1) was obtained due to the limit of resection length, and the pathology showed a 40% of residual tumor. The respective duration of operation was 3 and 7 hours, and the intraoperative blood loss was 30 and 200 mL, respectively. endotracheal tube was removed after operation. The postoperative course of the patient with pCR was uneventful, and mediastinal drains were removed on postoperative day 9. The other patient with long-segmental tracheal resection had difficulty in expectoration which required bronchoscopic sputum aspiration, and a transient swallowing dysfunction. The remainder of the patient’s postoperative course was uneventful, and the mediastinal drains were removed on postoperative day 17.

Long-term survival outcomes

For surgically-treated patients, the one with pCR was still in a disease-free status at 22 months follow-up, and surveillance CT and bronchoscopy demonstrated good luminal patency (Figure 3). The other patient with R1 resection had marked granulation tissue at the anastomotic site and tumor progression in the right main bronchus 3 months after operation. Repeated bronchoscopic debridement was required to relieve airway obstruction. The patient refused further anti-tumor treatment and eventually died 4 months later.

Figure 3 A case with radiologic complete response receiving operation. (A) Before neoadjuvant therapy: CT scan and bronchoscopy showed a tracheal tumor located 1.5 cm below the glottis occupying 90% of the tracheal lumen. (B) After two cycles of neoadjuvant therapy: CT scan showed a radiological complete response, bronchoscopy indicated a tumor regression reaction after stent removal. (C) Two weeks after operation: CT scan and bronchoscopy demonstrated good tracheal luminal patency. CT, computed tomography.

Four non-surgically-treated patients were all alive without any sign of disease progression after a median follow-up of 38.0 (30.5–43.0) months. Surveillance bronchoscopy revealed slight scarring and some point-like projections at the orifice of the right main bronchus (Figure 4). The median disease-free survival had not been reached for the entire cohort at the time of data analysis. Details in patients’ treatment and follow-up information were provided in Appendix 1.

Figure 4 A non-surgically-treated case with radiologic complete response. (A) before neoadjuvant therapy; CT and bronchoscopy showed a tracheal tumor in carina, extending 1.5 cm to right main bronchus. (B) After 4 cycles of immunochemotherapy and radiation: CT showed a significant tumor remission; bronchoscopy revealed slight scarring and some point-like projections at the orifice of the right main bronchus. CT, computed tomography.

Post-hoc analysis

In post-hoc analyses of tumor response, there were no significant predictors for a radiologic CR and disease-free survival (Figure 5).

Figure 5 Swimmer plot of overall survival. Each bar represents one patient. The left column shows clinical characteristics and radiological responses. CR, complete response; N, node; PD-L1, programmed death-ligand 1; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; T, tumor.

Discussion

This study represents the first one to investigate the effectiveness and safety of immunochemotherapy and treatment strategies for locally-advanced initially-unresectable tracheal SCC. Immunochemotherapy conferred a significant tumor response, and was associated with few side effects. No patient recurred/progressed, except one who refused further treatment. Surgical conversion was possible, but surgery was only indicated when R0 resection could be achieved.

Toripalimab, also known as JS-001, can block the interaction of PD-1 with its ligands and promote T cell activation in preclinical studies (19). One recent multicenter randomized phase III trial (CHOICE-01) demonstrated that toripalimab plus chemotherapy significantly improved progression-free survival in patients with treatment-naive advanced NSCLC (16). Moreover, the Neotorch Randomized Clinical Trial showed that toripalimab in combination with perioperative chemotherapy led to a significant improvement in event-free survival for patients with resectable stage III NSCLC (8). However, Immunotherapy strategy for tracheal SCC remains in its infancy, which often refers to the treatment protocols for NSCLC. Our study found all 6 patients responsive to toripalimab in combination with chemotherapy, with a radiologic PR and CR rate of 66.7% and 33.3%, respectively, suggesting that tracheal SCC might be an ideal candidate for immunotherapy. Osho et al. also reported a favorable response in a patient with recurrent locally aggressive tracheal SCC receiving nivolumab after the failure of additional radiation and different chemotherapy regimens, and there was no evidence of malignancy after 7 months of monoimmunotherapy (11). Tapias et al. found the degree of tumor infiltration by CD8+ immune cells were significantly higher in tracheal SCC compared to that of salivary-type tracheal tumors, contributing to a particularly good efficacy of immune checkpoint inhibitors in those patient population (20).

Induction immunochemotherapy may have a role for selected patients with initially-unresectable NSCLC after successful downstaging (9,10,21). Increasing studies have shown 39–50% of patients with locally-advanced initially-unresectable NSCLC becoming amenable to surgical resection after immunochemotherapy, with pCR rates ranging from 20% to 35% (10,22). Thus, the reduction of tumor burden after immunochemotherapy provides a great potential of resection for tracheal SCC. In this study, 2 of 6 patients initially deemed unresectable received operation after immunochemotherapy, and 1 patient achieved an R0 resection and pCR. This patient had an uneventful postoperative course, and remains in a disease-free status after 22 months follow-up. It should be noted that a satisfactory response to immunochemotherapy does not always reduce the need for aggressive surgeries for tracheal SCC. Although organ preservation technique after neoadjuvant immunochemotherapy has been applied in selected central type NSCLC patients (23), the risks of surgical complications would be higher after tracheal resection than lung resections. It is unclear what benefit surgery might have for patients with initially-unresectable tracheal SCC who had disease control with immunochemotherapy, and if they would achieve better outcomes with definitive immunochemotherapy instead. Just as the other surgically-treated patients who received various tracheal release maneuvers, a positive margin (R1) was still reported, and the patient presented with difficulty in postoperative expectoration and more formidable anastomotic complications which required repeated bronchoscopic sputum aspiration and debridement. Instead, as shown in our results, non-surgically-treated patients had a comparable overall survival compared to surgical patients, even relatively longer survival compared to those with incomplete resection. Therefore, we perceived that surgery should not be recommended in the first place if R0 resection could not be achieved after initial immunochemotherapy because it is not associated with a proven benefit in either survival or quality of life.

Regarding the predictive markers for the effectiveness of immunochemotherapy, PD-L1 expression levels, tumor mutational burden, and driver gene status are well-recognized predictors in NSCLC (6). However, no reliable biomarkers have been identified for tracheal SCC in this study. There may be a correlation between PD-L1 expression and treatment efficacy in previous case report (11).

The TRAE profile was similar to that reported in phase I studies on toripalimab where near all patients had TRAE with the most AEs being mild (grade 1 or 2) (24). The majority of these AEs are consistent with the development of immune-related adverse events (irAEs) in patients with NSCLC receiving toripalimab combined with chemotherapy (6,16). No new and particular safety signals were identified in tracheal SCC, and AEs that occurred did not impede the feasibility of surgery and treatment discontinuation.

A number of limitations should be acknowledged in this study. Although this study represents the first and largest prospective study focusing on tracheal SCC, the number of enrolled patients is small, which is due mostly to an intrinsic limitation of the rarity of tracheal SCC. As reported by one recent epidemiologic study, the global age‑standardized rate of incidence of tracheal cancer was 2.9 per 10 million in 2022 (25). A small sample may limit statistical comparisons and impact result stability. Second, there was no clear definition of resectability, and the 4-cm threshold depended on patient characteristics and surgical expertise, which may lead to a variation in the selection of surgical candidates between institutions. Third, due to the insufficient pre-treatment tumor samples for genomic analyses, no reliable biomarkers were identified to predict response in initially-unresectable tracheal SCC. Thus, patients may be subject to higher-than-expected incomplete resections. Further randomized controlled trials with more patients and comprehensive exploration of tumor molecular characterization were urgently needed to strike a balance between overtreatment (i.e., incomplete resection) and undertreatment (i.e., amenable to resection but not offered), in order to optimize treatment algorism for every patient on the basis of their disease status, treatment response, and molecular features.

Conclusions

First-line treatment with toripalimab plus paclitaxel and carboplatin chemotherapy demonstrated a potential efficacy in initially-unresectable locally-advanced tracheal SCC. The safety profile was manageable, without new safety concerns compared with NSCLC. Further multi-center randomized controlled trials were needed to verify these findings and explore the role of immunochemotherapy in the neoadjuvant setting.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the TREND reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-0773/rc

Data Sharing Statement: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-0773/dss

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-0773/prf

Funding: This study was supported by the National Natural Science Foundation of China (No. 82473466).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-0773/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of Shanghai Pulmonary Hospital (No. L20-448, Dec 2020). All patients provided written informed consent before enrollment, and patients had the right to withdraw from the study at any time and for any reason.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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