Status:
ACTIVE_NOT_RECRUITING
Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 squ...
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 squ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04844385
Start Date
February 20 2021
End Date
December 20 2024
Last Update
February 9 2024
Active Locations (1)
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1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000