A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- progression-free survival rate
研究概览
简要总结
This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
详细描述
This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed esophageal squamous cell carcinoma
- •patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients with lymph node metastasis in the supraclavicular region)
- •ECOG performance status 0-1
- •no previous chest radiotherapy, immunotherapy or biotherapy.
- •hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- •serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- •bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- •FEV1 >0.8 L
- •CB6 within normal limits
- •patients and their family signed the informed consents
排除标准
- •previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
- •contraindication for chemotherapy
- •women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- •women who has the probability of pregnancy without contraception
- •tendency of hemorrhage
- •in other clinical trials within 30 days
- •addicted in drugs or alcohol, AIDS patients
- •uncontrollable seizure or psychotic patients without self-control ability
- •severe allergy or idiosyncrasy
- •not suitable for this study judged by researchers
研究组 & 干预措施
Cohort A
Patients in cohort A receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 60Gy combined with Capecitabine.
干预措施: Toripalimab (Drug)
Cohort A
Patients in cohort A receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 60Gy combined with Capecitabine.
干预措施: Paclitaxel-albumin (Drug)
Cohort A
Patients in cohort A receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 60Gy combined with Capecitabine.
干预措施: Nedaplatin (Drug)
Cohort A
Patients in cohort A receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 60Gy combined with Capecitabine.
干预措施: radiation therapy at a total dose 60 Gy (Radiation)
Cohort A
Patients in cohort A receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 60Gy combined with Capecitabine.
干预措施: Capecitabine (Drug)
Cohort B
Patients in cohort B receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 50Gy combined with Capecitabine.
干预措施: Toripalimab (Drug)
Cohort B
Patients in cohort B receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 50Gy combined with Capecitabine.
干预措施: Paclitaxel-albumin (Drug)
Cohort B
Patients in cohort B receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 50Gy combined with Capecitabine.
干预措施: Nedaplatin (Drug)
Cohort B
Patients in cohort B receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 50Gy combined with Capecitabine.
干预措施: Capecitabine (Drug)
Cohort B
Patients in cohort B receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 50Gy combined with Capecitabine.
干预措施: radiation therapy at a total dose 50 Gy (Radiation)
结局指标
主要结局
progression-free survival rate
时间窗: 18-month
次要结局
- Clinical response rate(2 months after radiotherapy)
- locoregional recurrence-free survival(18-month)
- distant metastasis-free survival(18-month)
- the rate of grade 3 or 4 toxicities according to CTCAE4.0(1 year after therapy)
- Quality of life assessed by QLQ-C30(12 months)
- overall survival rate(18-month)
研究者
Hui Liu
Professor
Sun Yat-sen University