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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient shall sign the Informed Consent Form;
- •Aged ≥ 18 years;
- •Patients with definitely incidental SCLC confirmed by pathological results after radical resection of lung cancer;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •Life expectancy is at least 12 weeks;
- •Good function of other major organs (liver, kidney, hematological system, etc.);
- •Fertile female patients must undergo a pregnancy test within 7 days before the start of treatment with a negative result; and reliable contraceptive measures (such as intrauterine devices, contraceptives and condoms) should be used during the trial and within 30 days after its completion;
- •Fertile male subjects must use condoms for contraception during the trial and within 30 days after its completion.
排除标准
- •Patients with a malignancy other than SCLC within five years prior to the start of this trial;
- •Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
- •With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- •Participants who are allergic to the test drug or any auxiliary materials;
- •Participants with active hepatitis B, hepatitis C or HIV;
- •Participants with Interstitial lung disease currently;
- •Pregnant or lactating women;
- •Any malabsorption;
- •Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- •Other factors that researchers think it is not suitable for enrollment.
研究组 & 干预措施
Postoperative Adjuvant Chemotherapy
In this arm, enrolled subjects will receive postoperative adjuvant chemotherapy, totaling 4 cycles, with each cycle lasting 3 weeks.
干预措施: Etoposide (Drug)
Postoperative Adjuvant Chemotherapy
In this arm, enrolled subjects will receive postoperative adjuvant chemotherapy, totaling 4 cycles, with each cycle lasting 3 weeks.
干预措施: Platinum (Drug)
Postoperative Chemotherapy Combined with Toripalimab Maintenance
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.
干预措施: Etoposide (Drug)
Postoperative Chemotherapy Combined with Toripalimab Maintenance
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.
干预措施: Platinum (Drug)
Postoperative Chemotherapy Combined with Toripalimab Maintenance
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.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: 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.
次要结局
- Health related quality of life (HRQol)：EORTC-QLQ-C30(up to 5 months)
- Overall Survival (OS)(up to 60 months)
- Health related quality of life (HRQol)：LC13(up to 5 months)
- Treatment-related adverse event (TRAE)(Up to 30 months)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China