Actively Recruiting
Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-24
30
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are: 1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants? 2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy? Participants will: * Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol. * Visit the clinic for regular checkups and tests throughout the treatment period. * Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety. * Provide hematologic and tissue samples to explore biomarkers. This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.
CONDITIONS
Official Title
Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older and 80 years or younger
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed primary endometrial cancer of specified types
- Locally recurrent or oligometastatic endometrial cancer after initial treatment with 5 or fewer lesions
- At least one measurable lesion suitable for radiotherapy
- Tumor samples available for biomarker testing
- Expected survival of at least 6 months
- Normal major organ function based on blood tests within 7 days before enrollment
- Resolved prior treatment toxicities to grade 1 or less except allowed exceptions
- Use of medically recognized contraception during and for 3 months after treatment for non-sterilized females of childbearing potential
- Negative pregnancy test within 7 days before enrollment and not breastfeeding
You will not qualify if you...
- Active or history of autoimmune disease requiring treatment except resolved vitiligo or childhood asthma
- Current use of immunosuppressive or corticosteroid therapy above specified doses within 2 weeks prior to enrollment
- Prior severe immune-related adverse events from immunotherapy
- Poorly controlled heart disease or recent heart attacks
- Coagulation disorders, bleeding tendencies, or anticoagulant therapy
- Recent cancer treatments within 4 weeks or unresolved adverse events from prior treatments
- Uncontrolled fluid accumulation requiring drainage
- Significant recent or ongoing bleeding
- Known bleeding or clotting disorders
- Active infections or unexplained fever above 38.5°C
- Lung diseases such as fibrosis or pneumonitis
- Immune deficiencies or active hepatitis infections
- Recent use of other investigational drugs or local treatments without recovery
- History or current other cancers except certain cured skin or cervical cancers
- Planned or ongoing systemic anti-tumor treatments during study
- Recent or planned live vaccinations within 4 weeks prior to or during study
- Other severe diseases or conditions that may affect safety or data collection as judged by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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