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

Phase 2

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: QL1706

• Registration Number: NCT05490719
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-19
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-09-01
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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 before the first use of the study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QL1706 plus Chemotherapy and Radiotherapy	QL1706	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.

Primary Outcome Measures

Name	Time	Method
PFS assessed by investigators	Up to approximately 2 years.	Progression-free survival assessed by investigators

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin cancer hospital; 🇨🇳 Tianjin, Tianjin, China