Shanghai Pulmonary Hospital
Shanghai, China, 200433
NCT Number: NCT07097948
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Shanghai, China, 200433
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specified dose on specified days.
Specified dose on specified days.
Specified dose on specified days.
Time frame: up to 60 months
Defined as the time from the initiation of treatment to the first confirmed disease recurrence or death from any cause, whichever occurs first.
Time frame: up to 60 months
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.
Time frame: up to 5 months
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.
Time frame: up to 5 months
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.
Time frame: Up to 30 months
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Contact information is provided by the study sponsor or research team.
Shanghai Pulmonary Hospital, Shanghai, China
Other
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study
Acronym: Adjuvant
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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