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

Study Overview
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Brief Summary
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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.

Official Title
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A Single Arm, Multicenter Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: QL1706


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects participate voluntarily and sign informed consent. age:18-75 years, male or female. 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. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). Exclusion Criteria: Patients who have a history of esophageal cancer surgery. Previous history of fistula caused by primary tumor infiltration. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention. Major surgery or serious trauma within 4 weeks before the first use of the study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL1706 plus Chemotherapy and Radiotherapy<br>Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week. QL1706 will be administered at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administered up to 1 year. Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24. | Drug: QL1706<br>* QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS assessed by investigators | Progression-free survival assessed by investigators | Up to approximately 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 1year and 3years | 
| ORR | Objective Response Rate，Complete Response plus Partial Response | Up to approximately 2 years | 
| DoR | Duration of Response | Up to approximately 2 years | 
| The rates and severity of Adverse Events, Serious Adverse Events | The rates and severity of Adverse Events, Serious Adverse Events | Through study completion, up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706