Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase II randomized study is to determine the efficacy and toxicity of toripalimab plus neoadjuvant chemotherapy combined with chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Capecitabine; Nedaplatin; Paclitaxel

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 T2-4 N0-3 M0 confirmed by CT or MRI

• 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 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