A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- progression-free survival rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Hui Liu
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Toripalimab
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.
Intervention: Paclitaxel-albumin
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.
Intervention: Nedaplatin
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.
Intervention: radiation therapy at a total dose 60 Gy
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.
Intervention: Capecitabine
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.
Intervention: Toripalimab
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.
Intervention: Paclitaxel-albumin
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.
Intervention: Nedaplatin
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.
Intervention: Capecitabine
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.
Intervention: radiation therapy at a total dose 50 Gy
Outcomes
Primary Outcomes
progression-free survival rate
Time Frame: 18-month
Secondary Outcomes
- 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)