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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance Therapy Group with Adebrelimab Combined with Apatinib | Experimental | 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. |
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| Maintenance Therapy Group with Adebrelimab | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from randomization until tumor progression (as defined by RECIST 1.1 criteria) or death from any cause, whichever occurs first. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, OS | The time from randomization until death from any cause. For subjects who are lost to follow-up before death, the last follow-up time is usually counted as the time of death. | 36 months |
| Objective response rate, ORR |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of deep venous thrombosis or pulmonary embolism within 1 month prior to the first dose of the study drug. Clinically insignificant thrombosis, such as non-obstructive biliary tract-related clots, is not an exclusion criterion. Any history of myocardial infarction, severe/unstable angina, NYHA class 2 or higher heart failure, or left ventricular ejection fraction (LVEF) < 50% on echocardiography, stroke, transient ischemic attack, coronary or peripheral artery bypass surgery, or any acute coronary syndrome, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure within 6 months prior to the first dose of the study drug. Uncontrolled moderate-to-severe hypertension (SBP > 180 mmHg or DBP > 100 mmHg). Poorly controlled arrhythmias (including QTcF interval ≥ 470 ms for females); abnormal corrected QT interval (QTcF) on electrocardiogram (ECG) at rest during screening, with QTcF ≥ 470 ms for females on average of three ECGs taken at least 5 minutes apart. Pericarditis/clinically significant pericardial effusion.Cardiomyopathy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Peng Associate Professor, Medical Doctor | Contact | 8613521361934 | pengp1999@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences | Beijing, China | Beijing Municipality | 100032 | China |
Sharing research findings through article publication
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| 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. |
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The proportion of patients whose tumor volume decreases by a predetermined amount and maintains this reduction for the minimum required duration. It is the sum of the complete response (CR) and partial response (PR) rates. In other words, ORR = CR + PR.
| 36 months |
| Disease control rate, DCR | The percentage of evaluable patients who achieve a response (PR + CR) or stable disease (SD) after treatment. Simply put, DCR = CR + PR + SD, according to the RECIST criteria for at least 4 weeks. | 36 months |
| Duration of Overall Response, DOR | The time from when a patient first achieves a CR or PR to disease progression. | 36 months |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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