Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer: A Phase I/II Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3% to 13%. CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months. Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival. Recently, several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy. In a prospective study, 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 10.1 months and overall survival of 21.4 months, which was longer than chemoimmunotherapy. Another study demonstrated not only thoracic radiotherapy, but also radiotherapy to metastatic lesions could ameliorate survival. Therefore, we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer.
详细描述
Trial design: To enroll 150 patients diagnosed with extensive-stage small-cell lung cancer to receive first-line chemoimmunotherapy with or without radiotherapy to all residual lesions.
Primary endpoint: Progression-free Survival Secondary endpoint: Overall Survival, Objective Response Rate, Duration of Response, Disease Control Rate.
Randomization: All the enrolled patients would be randomly assigned to chemoimmunotherapy group and chemoimmunotherapy with radiotherapy group using random table method.
All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy (etoposide and cisplatin & carboplatin with Adebrelimab). Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years.
Chemoimmunotherapy: Etoposide 80-100mg/m2 day 1, 2, 3 and cisplatin 75-80mg/m2 day 1 & carboplatin AUC 5 day 1 and Adebrelimab 1200mg day 1 q3w totally 4 to 6 cycles.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old;
- •ECOG 0-1;
- •Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;
- •Small-cell lung cancer;
- •Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
- •Signature of inform consent.
排除标准
- •Younger than 18 years old or older than 70 years old;
- •ECOG>1;
- •Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;
- •Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- •Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
- •No signature of inform consent.
研究组 & 干预措施
Chemoimmunotherapy group
Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by immunotherapy maintenance to 2 years.
干预措施: Chemoimmunotherapy (Drug)
Chemoimmunotherapy with radiotherapy group
Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by radiotherapy to all residual lesions and immunotherapy maintenance to 2 years.
干预措施: Radiotherapy to all residual lesions (Radiation)
Chemoimmunotherapy with radiotherapy group
Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by radiotherapy to all residual lesions and immunotherapy maintenance to 2 years.
干预措施: Chemoimmunotherapy (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 3 years
The survival time from diagnose of the disease to progression of the disease
次要结局
- Overall Survival(3 years)
研究者
Dong Qian
M.D.
Anhui Provincial Hospital