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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Single Arm, 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490719
• Other study ID #: QL1706-IIT-02
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Qingsong Pang
• Phone: 0862223340123
• Email: pangqingsong2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: September 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Tianjin cancer hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS assessed by investigators	Progression-free survival assessed by investigators	Up to approximately 2 years.
Secondary	OS	Overall survival	1year and 3years
Secondary	ORR	Objective Response Rate,Complete Response plus Partial Response	Up to approximately 2 years
Secondary	DoR	Duration of Response	Up to approximately 2 years
Secondary	The rates and severity of Adverse Events, Serious Adverse Events	The rates and severity of Adverse Events, Serious Adverse Events	Through study completion, up to approximately 2 years