A Phase II Study of CRT Combined With QL1706 in ESCC Patients
A Single Arm, 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
Tianjin Medical University Cancer Institute and Hospital
39 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
Interventions
QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05490719