Actively Recruiting
A Phase II Study of Cadonilimab With Paclitaxel, Cisplatin, and Radiation for Locally Recurrent and Oligometastatic Endometrial Carcinoma
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-24
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of cadonilimab with paclitaxel, cisplatin, and radiation therapy for women with locally recurrent and oligometastatic endometrial carcinoma. This phase II trial aims to assess the treatment's impact on overall response rate, progression-free survival, disease control rate, overall survival, and safety. It also seeks to identify biomarkers that may help guide the use of immune-oncology drugs in this combination therapy. Participants will receive intravenous infusions of cadonilimab every three weeks for up to 24 months or until certain conditions occur. Chemotherapy with paclitaxel and cisplatin is given every three weeks for 6 to 8 cycles, with alternatives available if needed. Radiation therapy will target all tumor lesions, including original sites and metastases, using various techniques and doses, typically starting after initial systemic therapy cycles. Throughout the study, participants will have regular clinic visits for checkups, scans, and blood and tissue sample collection to monitor treatment effects and safety. Researchers will track progression-free survival over up to 60 months and assess response rates, overall survival, disease control, and adverse events over about two years. The study includes careful monitoring and biomarker analysis to better understand treatment outcomes.
CONDITIONS
Brief Title
Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 80 years
- Written informed consent signed before any trial procedures
- ECOG performance status 0 or 1
- Newly diagnosed with specified types of endometrial cancer confirmed by pathology
- Locally recurrent or oligometastatic endometrial cancer with 5 or fewer lesions
- At least one measurable tumor site suitable for radiotherapy
- Availability of tumor samples for biomarker analysis
- Expected survival of 6 months or more
- Normal major organ function within 7 days before enrollment, including specified blood counts and organ tests
- Resolved toxic reactions from prior treatments to grade 1 or less, with some exceptions
- Use of medically recognized contraception for childbearing potential females during treatment and 3 months afterward
- Negative pregnancy test within 7 days before enrollment and not breastfeeding
You will not qualify if you...
- Active or history of autoimmune diseases requiring treatment, except resolved childhood asthma or vitiligo
- Current use of immunosuppressive agents or corticosteroids exceeding specified doses
- History of severe immune-related adverse events from prior immunotherapy
- Poorly controlled heart diseases or recent significant cardiac events
- Coagulation disorders or ongoing anticoagulant therapy
- Recent cancer treatments within 4 weeks or unresolved adverse effects from prior therapies
- Uncontrolled effusions or significant recent bleeding
- Known bleeding or thrombotic disorders
- Active infection or fever above 38.5°C before treatment
- History or evidence of lung diseases affecting lung function
- Immune deficiencies or active hepatitis infections
- Use of other investigational drugs or radiotherapy shortly before enrollment
- History of other malignancies except certain cured skin or cervical cancers
- Planned systemic anti-tumor therapies during the study
- Use or expected use of live vaccines within 4 weeks before or during the study
- Other severe diseases or conditions judged to affect safety or data collection by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 cycles of chemotherapy (approximately 18 to 24 weeks) with continuous immunotherapy up to 24 months
Participants receive chemotherapy with Paclitaxel and Cisplatin every 3 weeks for 6 to 8 cycles or until disease progression or intolerable side effects. They also receive Cadonilimab every 3 weeks continuously for up to 24 months or until disease progression or other stopping criteria. Radiotherapy is given to all tumor lesions, usually starting after 2 to 6 cycles of systemic therapy or earlier for small solitary lesions.
Chemotherapy and immunotherapy infusions every 3 weeks; radiotherapy timing varies based on tumor lesions
Duration - Up to 60 months after enrollment
Participants are monitored for safety and disease status after treatment completion, with assessments including adverse event recording every 3 months.
Visits every 3 months
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jing Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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