To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT05490719

Condition: Esophageal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Cisplatin

Conditions: Keywords:
Esophageal Cancer
Concurrent chemoradiation
Immunotherapy
CTLA-4
PD-1
QL1706

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: QL1706
Description: QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
Arm group label: QL1706 plus Chemotherapy and Radiotherapy

Other name: Radiation

Other name: Taxol

Other name: Cisplatin

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.

Criteria for 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 before the first use of the study drug.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin cancer hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Status: Recruiting

Contact:
Last name: Qingsong Pang

Start date: August 1, 2022

Completion date: September 2025

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05490719

Login to your account

Did you forget your password?