Adebrelimab Plus Carboplatin/Paclitaxel Followed by Adebelizumab with or Without Apatinib in the Treatment of Advanced Recurrent/Metastatic Endometrial Cancer (A-CAPE): a Multicenter, Randomized, Controlled, Open-Label Clinical Trial
Summary
This study takes investigator-assessed Progression-Free Survival (PFS) as the primary endpoint, with plans to enroll 140 patients with advanced recurrent/metastatic endometrial cancer in a 1:1 ratio, randomized into an experimental group and a control group. The aim is to evaluate the efficacy and safety of Adebelimab (PD-L1) combined with Carboplatin/Paclitaxel treatment, followed by maintenance therapy with or without Apatinib in patients with advanced recurrent/metastatic endometrial cancer. Additionally, based on molecular testing results, the study will explore the PFS and Overall Survival (OS) of patients with Deficient Mismatch Repair/Microsatellite Instability-High(dMMR/MSI-H) and Proficient Mismatch Repai/Microsatellite Stability (pMMR/MSS) endometrial cancer, providing new precision treatment options for patients with recurrent and metastatic endometrial cancer.
Timeline
- Start
- 2025-04-01
- Primary completion
- 2029-04-01
- Completion
- 2029-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adebelimab | Unknown | 1200 mg | Intravenous |
| Subject | Rivoceranib | Small molecule | 250 mg | Oral |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |