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

Tianjin Medical University

Status and phase: Enrolling; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: QL1706

Study type: Interventional

Funder types: Other

Identifiers

NCT05490719

QL1706-IIT-02

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

QL1706 plus Chemotherapy and Radiotherapy

Experimental group

Description:

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.

Treatment:

Drug: QL1706