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Small cell lung cancer (SCLC) is highly malignant and aggressive, with most patients presenting with metastases at diagnosis. For postoperatively incidentally detected SCLC (identified unexpectedly in pathological examinations after surgery), conventional adjuvant chemoradiotherapy has shown limited efficacy, characterized by high recurrence rates and suboptimal long-term survival.Notably, advances in immunotherapy have transformed SCLC management. The EXTENTORCH trial, a pivotal study published in JAMA Oncology, demonstrated that toripalimab plus chemotherapy significantly improved outcomes in extensive-stage SCLC (ES-SCLC), achieving a reduced risk of progression or death (HR=0.67, 95% CI 0.54-0.82, P<0.001) with manageable safety, marking a substantial therapeutic breakthrough. Given the proven efficacy of toripalimab in ES-SCLC, there is a strong rationale to extend this strategy to postoperatively incidentally detected SCLC. This trial aims to evaluate the efficacy and safety of toripalimab as adjuvant maintenance therapy in this cohort, with the objective of reducing recurrence and enhancing long-term survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative Adjuvant Chemotherapy | Active Comparator | In this arm, enrolled subjects will receive postoperative adjuvant chemotherapy, totaling 4 cycles, with each cycle lasting 3 weeks. |
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| Postoperative Chemotherapy Combined with Toripalimab Maintenance | Experimental | In this arm, enrolled subjects will first receive postoperative chemotherapy (4 cycles, 3 weeks per cycle), followed by toripalimab for immunological maintenance therapy, administered once every 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) | Defined as the time from the initiation of treatment to the first confirmed disease recurrence or death from any cause, whichever occurs first. | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from the date of initial treatment to death from any cause. For patients still alive at the time of analysis, the date of last contact will be used as the censoring date. Survival curves will be estimated using the Kaplan-Meier method. | up to 60 months |
| Health related quality of life (HRQol):EORTC-QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Zhang, PhD | Contact | 02165115006 | zhangpeng1121@tongji.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | China | 200433 | China |
The researchers will consider whether IPD is available to other researchers only after the paper is published.
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For patients with postoperatively incidentally detected small cell lung cancer, all enrolled patients will be randomized into two groups: one group receiving toripalimab combined with platinum-based chemotherapy, and the other group receiving platinum-based chemotherapy alone.
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| Platinum | Drug | Specified dose on specified days. |
|
| Toripalimab | Drug | Specified dose on specified days. |
|
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 , Version 3). EORTC's QLQ-C30 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. |
| up to 5 months |
| Health related quality of life (HRQol):LC13 | The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (LC13, Version 3).The items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality. | up to 5 months |
| Treatment-related adverse event (TRAE) | TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants. | Up to 30 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D010984 | Platinum |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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