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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