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Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin/Carboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer
The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.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 iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin 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、tissue and stool 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 cervical cancer as well as identify biomarkers to better guide treatment strategies.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Shandong Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong Recruiting, China
Start Date
February 28, 2025
Primary Completion Date
July 31, 2026
Completion Date
December 31, 2028
Last Updated
April 24, 2025
36
ESTIMATED participants
Paclitaxel and Cisplatin/ Carboplatin
DRUG
Iparomlimab and Tuvonralimab
DRUG
Radiotherapy
RADIATION
Lead Sponsor
Shandong Cancer Hospital and Institute
NCT06349642
NCT05639972
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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