Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT06321068
Brief Summary:
Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma
Detailed Description:
Phase II is a single-arm safety and efficacy study to explore the safety and initial efficacy of BAT1308 combined with platinum-containing chemotherapy. The first 6 patients (using 3+3 method) were included in the safe induction period, and 3 subjects were included first DLT assessment was performed. If there were less than 2 cases of DLT, 3 subjects were further included for DLT assessment Less than 2 cases of DLT in the total 6 cases were formally entered into the phase II study, if the phase II combination drug regimen was safe Phase II enrollment was stopped and phase III study was entered when the full treatment was controllable and the efficacy was in line with expectations. Phase I study is BAT1308 in combination with platinum-containing chemotherapy vs. placebo plus platinum-containing chemotherapy for advanced first-line treatment or A randomized, double-blind, multicenter clinical study of patients with recurrent dMMR endometrial cancer. PFS As the primary endpoint, optimal design. Stratified by the following random factors Histological randomization: according to disease status (stage III, IV, or relapse), prior pelvic extrinsic release Patients were stratified by treatment history (yes or no).
Study:
NCT06321068
Study Brief:
Protocol Section:
NCT06321068