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Recruiting Phase 2 NCT05490719

A Phase II Study of CRT Combined With QL1706 in ESCC Patients

Trial Parameters

Condition Esophageal Squamous Cell Carcinoma
Sponsor Tianjin Medical University Cancer Institute and Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 39
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-08-01
Completion 2024-09-01
Interventions
QL1706

Brief Summary

This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial(IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.

Eligibility Criteria

Inclusion Criteria: 1. Subjects participate voluntarily and sign informed consent. 2. age:18-75 years, male or female. 3. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0. 4. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). Exclusion Criteria: 1. Patients who have a history of esophageal cancer surgery. 2. Previous history of fistula caused by primary tumor infiltration. 3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation. 4. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention. 5. Major surgery or serious trauma within 4 weeks

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