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

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05490719

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: QL1706	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single Arm, Multicenter 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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QL1706 plus Chemotherapy and Radiotherapy 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.	Drug: QL1706 QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody. Other Names: Radiation Taxol Cisplatin

Arm

Intervention/Treatment

Experimental: QL1706 plus Chemotherapy and Radiotherapy

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.

Drug: QL1706

QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.

Other Names:

Radiation

Taxol

Cisplatin

Outcome Measures

Primary Outcome Measures

PFS assessed by investigators [Up to approximately 2 years.]
Progression-free survival assessed by investigators

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.