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A Phase II, Single-arm, Multicenter Clinical Trial of Definitive Treatment With Cadonilimab, Paclitaxel, Cisplatin and Radiation for the Treatment of Locally Recurrent and Oligometastatic Endometrial Carcinoma
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.
Details
| Lead sponsor | Shandong Cancer Hospital and Institute |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2024-06-13 |
| Completion | 2026-09 |
Conditions
- Endometrial Neoplasms
- Neoplasm Recurrence, Local
- Neoplasm Metastasis
Interventions
- Paclitaxel and Cisplatin
- Cadonilimab
- Radiotherapy
Primary outcomes
- Progression-Free Survival — Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months
Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first.
Countries
China