NCT07900256Not yet recruitingPhase 2
A Preliminary Exploratory Study of Cadonilimab Combined With Progestin for Fertility-Sparing Treatment in Early Endometrial Cancer
A Study on the Safety and Efficacy of Cadonilimab Combined With Progestin in Fertility-Sparing Treatment for Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
This is a single-center, prospective, open-label, single-arm exploratory phase II study evaluating the efficacy and safety of cadonilimab combined with megestrol acetate as fertility-sparing treatment for patients with progestin-resistant early-stage endometrial cancer. Approximately 10 participants will be enrolled. Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. The primary outcomes are complete response rate (CRR) and duration of complete response (DOR). The study will also assess treatment-related adverse events, recurrence, pregnancy, and live birth outcomes.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Apr 2033
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Endometrial cancer
- NCT number
- NCT07900256
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 1 Oct 2026 to the primary completion date, 1 Apr 2033
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving treatment with an immune checkpoint inhibitor.
- Patients who require or request treatment with other anticancer agents, such as chemotherapy.
- Patients requiring daily treatment with corticosteroids or other immunosuppressive agents.
Other illness
- Patients who are allergic to immune checkpoint inhibitor drugs;
- Patients with a history of cardiovascular disease, including severe hypertension, frequent arrhythmias, or myocardial infarction.
- Patients with a history of hepatitis B or hepatitis C infection and a detectable viral load.
- Patients with severe obstructive pulmonary disease.
- Patients with autoimmune diseases.
- Patients with active pulmonary tuberculosis.
- Patients with a history of other malignancies.
- Patients with a history of other malignancies.
Lab values
- Patients with abnormal complete blood count results or impaired hepatic or renal function.
Who the study is looking for
- Aged 18-45 years.
- Endometrioid adenocarcinoma.
- Grade 1 (G1).
- MRI rules out myometrial invasion.
- MRI rules out myometrial invasion.
- Progestin resistance (failure to achieve remission, partial response, or disease progression after 6 months of progestin therapy).
- Strong desire to preserve fertility.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.