Recurrent/Metastatic Endometrial CancerPhase 2A-CAPENCT06771154
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
A Phase 2 study testing Adebelimab Combined with Apatinib and Adebelimab in people with Recurrent/Metastatic Endometrial Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent/Metastatic Endometrial Cancer
- What is being tested?
- Adebelimab Combined with Apatinib and Adebelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histologically or cytologically confirmed diagnosis of primary advanced (FIGO stage III/IV) endometrial cancer patients, or first recurrent endometrial cancer with low likelihood of cure through radiotherapy, surgery, or a combination of both.
- Pathological type is not limited (excluding sarcomas for all pathological types).
- MMR/MSI test report available, or tumor tissue for MMR/MSI status testing can be provided.
- Patients with endometrial cancer who have not received systemic antitumor therapy or have ≤1 line of recurrence (including neoadjuvant, postoperative adjuvant chemotherapy, and concurrent chemotherapy), or have relapsed after completing systemic antitumor therapy with PD ≥ 6 months (limited to first recurrence).
- Discontinuation interval of ≥4 weeks for previous radiotherapy, chemotherapy, or hormone therapy; for patients who have failed platinum-based chemotherapy, a platinum-free interval of ≥6 months is required.
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- ECOG score: 0-2, with an expected survival of ≥6 months.
- Patients have good organ function: without having received blood products, granulocyte colony-stimulating factor, interleukin-11, thrombopoietin, or thrombopoietin receptor agonists within 14 days prior to the first administration of the treatment drug in this protocol.Neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 80 × 10^9/L; Hemoglobin ≥ 80 g/L; Albumin ≥ 28 g/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT, AST ≤ 3 times ULN (without liver metastasis) or ≤ 5 times ULN (in case of liver metastasis); Serum creatinine ≤ 1.5 times ULN; Coagulation function requirements: International Normalized Ratio (INR) ≤ 1.5 times ULN, Prothrombin Time (PT) ≤ 1.5 times ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN; Corrected serum electrolytes within normal range.
- Thyroid function: Thyroid-Stimulating Hormone (TSH) level ≤ 1 × ULN, or if TSH is not within the normal range, Free T4 ≤ 1 × ULN.
- Fertile women must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and agree to use appropriate contraception during the trial period and for 3 months after the last dose of the investigational drug.
- Signed a written informed consent form and expected to have good compliance with the study protocol.
Who cannot join
- Individuals with known allergy or severe allergic reactions to the study drug or any of its excipients.
- Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; prior treatment with small molecule anti-angiogenic targeted drugs (TKIs).
- Presence of other non-curable malignant tumors, except for those that have been definitively cured or locally curable cancers, such as skin basal or squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.
- Primary malignant tumors of the central nervous system, meningeal metastases, symptomatic brain metastases, or newly diagnosed and untreated brain metastases.
- Receipt of the following medications or treatments prior to the first dose of the study drug. Major surgery or trauma within 6 weeks with incomplete recovery (tissue biopsy for diagnostic purposes and procedures such as peripherally inserted central catheter [PICC] placement or port-a-cath implantation are allowed). Requirement for continuous high-dose systemic corticosteroids (>10 mg/day of prednisone or equivalent) or other systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, tacrolimus, cyclosporine, mycophenolate mofetil, antithymocyte globulin, anti-tumor necrosis factor drugs), and the need for continued treatment after enrollment. [Note]: Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed.
- History of severe infection within 90 days, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active tuberculosis, patients with positive hepatitis B surface antigen (HBsAg+) and/or positive hepatitis B core antibody (HBcAb+) require hepatitis B virus deoxyribonucleic acid (HBV DNA) testing; if HBV DNA copy number is <1000 cps/mL or below the lower limit of detection at the research center, they may participate in the study and use anti-HBV drugs as prescribed, patients with positive hepatitis C virus antibody (HCV Ab+) require HCV RNA testing. HCV RNA-negative (defined as below the lower limit of detection at the research center) may participate in the study; human immunodeficiency virus (HIV) infection (anti-HIV positive).
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- Receipt of first-line or second-line anti-cancer drug treatment within 4 weeks prior to the first dose; receipt of systemic treatment with herbs or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) with anti-cancer indications within 2 weeks prior to the first dose.
- Clinically significant cardiovascular disease, including but not limited to:
- 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.
- Presence of active autoimmune disease or immunodeficiency, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.
- Pregnant or lactating women, or women of childbearing potential who are unwilling or unable to use effective contraceptives (applicable to both male and female subjects) until at least 6 months after the last trial treatment, confirmed by blood or urine HCG testing.
- Uncontrolled diabetes (referring to large fluctuations in blood glucose despite standard insulin therapy and frequent blood glucose monitoring, affecting the patient's life and frequent occurrences of hypoglycemia).
- Subjects with unsatisfactory asthma control despite systemic treatment with bronchodilators.
- Subjects who have undergone or plan to undergo solid organ or hematological system transplants during the study period (excluding corneal transplants).
- Currently participating in an interventional clinical study treatment or having received other trial drugs or study devices within 4 weeks prior to the first dose; subjects who have not fully recovered from toxicity and/or complications resulting from any intervention prior to the first dose.
- Abnormal coagulation function (INR > 1.5 or prothrombin time [PT] > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency, or ongoing thrombolytic or anticoagulant treatment.
- History of psychoactive drug abuse that cannot be discontinued or presence of psychiatric disorders.
- Subjects with genetic or acquired bleeding disorders or coagulation dysfunction (eligibility based on investigator's judgment).
- History of cerebrovascular accident or transient ischemic attack within 6 months.
- Conditions that increase the risk associated with participating in the study or the study drug and, in the investigator's judgment, render the patient unsuitable for enrollment.
- Other conditions deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences
Beijing, China, Beijing Municipality, 100032
Peng Peng Associate Professor, Medical Doctor, 86+13521361934, pengp1999@163.com
About this study
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.
- Conditions
- Recurrent/Metastatic Endometrial Cancer
- Being tested
- Adebelimab Combined with Apatinib, Adebelimab
- Keywords
- Recurrent/Metastatic Endometrial Cancer, Adebrelimab, Apatinib, PD-L1, maintenance immune-targeted combination therapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebelimab Combined with ApatinibDrug
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.
AdebelimabDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Adebelimab Combined with Apatinib |
| 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. Receives: Drug: Adebelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (4)
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.
Measured: 36 months
Objective response rate, ORR
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.
Measured: 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.
Measured: 36 months
Duration of Overall Response, DOR
The time from when a patient first achieves a CR or PR to disease progression.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Metastatic Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771154
- Sponsor's protocol ID
- PekingUMCH-EC(A-CAPE)
- Acronym
- A-CAPE
- Status last verified
- Dec 2024
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing research findings through article publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06771154
- Acronym / sponsor ID
- A-CAPE / PekingUMCH-EC(A-CAPE)
- Conditions
- Recurrent/Metastatic Endometrial Cancer
- Keywords
- Recurrent/Metastatic Endometrial Cancer, Adebrelimab, Apatinib, PD-L1, maintenance immune-targeted combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance Therapy Group with Adebrelimab Combined with Apatinib | Experimental | Drug: Adebelimab Combined with ApatinibChemotherapy 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. |
| Maintenance Therapy Group with Adebrelimab | Active comparator | Drug: AdebelimabChemotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Histologically or cytologically confirmed diagnosis of primary advanced (FIGO stage III/IV) endometrial cancer patients, or first recurrent endometrial cancer with low likelihood of cure through radiotherapy, surgery, or a combination of both.
- Pathological type is not limited (excluding sarcomas for all pathological types).
- MMR/MSI test report available, or tumor tissue for MMR/MSI status testing can be provided.
- Patients with endometrial cancer who have not received systemic antitumor therapy or have ≤1 line of recurrence (including neoadjuvant, postoperative adjuvant chemotherapy, and concurrent chemotherapy), or have relapsed after completing systemic antitumor therapy with PD ≥ 6 months (limited to first recurrence).
Key exclusion criteria (21 listed)
- Individuals with known allergy or severe allergic reactions to the study drug or any of its excipients.
- Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; prior treatment with small molecule anti-angiogenic targeted drugs (TKIs).
- Presence of other non-curable malignant tumors, except for those that have been definitively cured or locally curable cancers, such as skin basal or squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.
- Primary malignant tumors of the central nervous system, meningeal metastases, symptomatic brain metastases, or newly diagnosed and untreated brain metastases.
- Receipt of the following medications or treatments prior to the first dose of the study drug. Major surgery or trauma within 6 weeks with incomplete recovery (tissue biopsy for diagnostic purposes and procedures such as peripherally inserted central catheter [PICC] placement or port-a-cath implantation are allowed). Requirement for continuous high-dose systemic corticosteroids (>10 mg/day of prednisone or equivalent) or other systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, tacrolimus, cyclosporine, mycophenolate mofetil, antithymocyte globulin, anti-tumor necrosis factor drugs), and the need for continued treatment after enrollment. [Note]: Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebelimab Combined with ApatinibChemotherapy 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 | Maintenance Therapy Group with Adebrelimab Combined with Apatinib |
| AdebelimabChemotherapy 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. | Drug | Maintenance Therapy Group with Adebrelimab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 36 months
The time from randomization until tumor progression (as defined by RECIST 1.1 criteria) or death from any cause, whichever occurs first.
4 secondary outcomes
Overall survival, OS
Time frame: 36 months
Objective response rate, ORR
Time frame: 36 months
Disease control rate, DCR
Time frame: 36 months
Duration of Overall Response, DOR
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Yes. Sharing research findings through article publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebelimab Combined with Apatinib and Adebelimab in people with Recurrent/Metastatic Endometrial Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Peng Associate Professor, Medical Doctor (8613521361934, pengp1999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.