Phase II Study of LBL-024 Combined With Other Drugs for Treating Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LBL-024 combined with other drugs in treating patients with advanced oesophageal squamous cell carcinoma, a type of advanced solid tumor. This open-label, multicenter, Phase II clinical study aims to compare the LBL-024 combination therapy against another drug combination, focusing on how well the treatments control tumor growth and patient response rates. The study begins with a safety run-in period where a small group of patients receive the LBL-024 combination therapy for 21 days to monitor safety and tolerability. Following this, eligible participants will be randomly assigned in a 21 ratio to either the experimental group receiving LBL-024 combined with Paclitaxel and Cisplatin or 5-Fluorouracilcapecitabine plus cisplatin, or the control group receiving Tislelizumab combined with the same chemotherapy drugs. Oral and intravenous drug administrations are included, and the study plans to enroll up to 110 subjects. Participants will have regular visits for treatment administration and monitoring, including laboratory tests to check organ and bone marrow function, tumor assessments using RECIST 1.1 criteria, and evaluation of side effects. Researchers will measure outcomes such as the objective response rate, disease control rate, duration of response, and drug pharmacokinetics. Safety follow-up is conducted up to 28 days after stopping the study drug or before starting new anti-tumor therapy, with the total study period extending until the end of 2028.

A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]