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

Conditions

• Recurrent/Metastatic Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adebelimab Combined with Apatinib — DRUG
  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.
• Adebelimab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 1, 2025

Status verified

Dec 2024

Primary completion

Apr 1, 2029

Completion

Apr 1, 2029

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Maintenance Therapy Group with Adebrelimab 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; Adebelimab: 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) Adebelizumab: 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.
• Active Comparator: Maintenance Therapy Group with Adebrelimab
  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. Adebelimab, 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) Adebelizumab, 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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 36 months ]

Central Contacts

• Peng Peng Associate Professor, Medical Doctor
  8613521361934
  [email protected]