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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2029

Study Completion Date

April 1, 2029

Conditions
Recurrent/Metastatic Endometrial Cancer
Interventions
DRUG

Adebelimab Combined with Apatinib

"Chemotherapy Phase (Total of 6 cycles, each cycle 21 days) Carboplatin AUC 5 mg/mL/min, administered on the first day of each cycle. Paclitaxel 175 mg/m², intravenous infusion for 3 hours, administered on the first day of each cycle.~Adebelizumab, Fixed dose of 1200 mg per administration, on the first day of each cycle, until the end of chemotherapy or until treatment is discontinued due to disease progression, intolerable toxicity, or other reasons specified in the protocol.~Maintenance Therapy Phase (Each cycle 21 days) Adebelimab, Fixed dose of 1200 mg per administration, IV (intravenous), Q3W (every 3 weeks), on the first day of each cycle, for a maximum of two years; Apatinib, 250 mg, once daily (qd), orally (po). Treatment continues until disease progression, intolerable toxicity, or other reasons specified in the protocol result in discontinuation."

DRUG

Adebelimab

"Chemotherapy Phase (Total of 6 cycles, each cycle 21 days) Carboplatin AUC 5 mg/mL/min, administered on the first day of each cycle. Paclitaxel 175 mg/m², intravenous infusion for 3 hours, administered on the first day of each cycle.~Adebelizumab, Fixed dose of 1200 mg per administration, on the first day of each cycle, until the end of chemotherapy or until treatment is discontinued due to disease progression, intolerable toxicity, or other reasons specified in the protocol.~Maintenance Therapy Phase (Each cycle 21 days) Adebelimab, Fixed dose of 1200 mg per administration, IV (intravenous), Q3W (every 3 weeks), on the first day of each cycle, for a maximum of two years; Treatment continues until disease progression, intolerable toxicity, or other reasons specified in the protocol result in discontinuation."

Trial Locations (1)

100032

Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences, Beijing, China

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER