RecruitingPhase 2NCT05490719

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

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

39 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemoradiation (chemotherapy plus radiation at the same time) with a new immunotherapy drug called QL1706 in patients with advanced esophageal squamous cell cancer that cannot be surgically removed. Immunotherapy helps the immune system find and attack cancer cells. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is unresectable (cannot be surgically removed) at stage II–IVa - You have not had previous esophageal cancer surgery - You have at least one measurable tumor on scans - You volunteer to participate and sign informed consent **You may NOT be eligible if...** - You have had previous esophageal surgery - You have a fistula (abnormal tunnel) caused by your tumor - You are at high risk of gastrointestinal bleeding, esophageal fistula, or perforation - You have lost more than 10% of your body weight in the past 2 months without improvement - You had major surgery or significant injury within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL1706

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


Locations(1)

Tianjin cancer hospital

Tianjin, Tianjin Municipality, China

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NCT05490719


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