Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
NCT Number: NCT06532539
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometrial Neoplasms|Neoplasm Recurrence, Local|Neoplasm Metastasis
Interventions: DRUG: Paclitaxel and Cisplatin|DRUG: Cadonilimab|RADIATION: Radiotherapy
Sponsor: Shandong Cancer Hospital and Institute
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2026-05
Locations: Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China

Summary:
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.

Primary Outcome Measures: 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., 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
Secondary Outcome Measures: Objective Response Rate, ORR refers to the proportion of patients whose optimal response is complete or partial response, ORR refers to the proportion of patients whose optimal response is complete or partial response, through study completion, an average of 2 years|Overall Survival, The time interval from enrollment to death from any cause, The time interval from enrollment to death from any cause, assessed up to 60 months|Disease Control Rate, DCR refers to the proportion of patients whose optimal response is complete or partial response, or stable disease, DCR refers to the proportion of patients whose optimal response is complete or partial response, or stable disease, through study completion, an average of 2 years|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Number of participants with adverse events and severe as assessed by CTCAE v5.0, Data will be recorded before each chemotherapy cycle, before and after radiotherapy, and every 3 months during the follow-up period, an average of 2 years
Other Outcome Measures: Biomarker, CD8A, PD-1, PD-L1, CD68, panCK, CD56, CD155, TIGIT, TMB, MSI, STING, et al, Biomarkers will be recorded before each chemotherapy cycle, before and after radiotherapy, and every 3 months during the follow-up period, an average of 2 years