Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, CTLA-4, PD-1, QL1706
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.
Interventions
DRUGQL1706
QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by investigators | Up to approximately 2 years. | Progression-free survival assessed by investigators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1year and 3years | Overall survival |
| ORR | Up to approximately 2 years | Objective Response Rate，Complete Response plus Partial Response |
| DoR | Up to approximately 2 years | Duration of 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 |
Countries
China
Contacts
Primary ContactQingsong Pang
Outcome results
None listed