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NOT YET RECRUITING
NCT07172217
PHASE2

The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators: Primary evaluation indicator: Objective Response Rate (ORR) Secondary evaluation indicators: Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival \[mOS\] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).

Official title: Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Iparomlimab and Tuvonralimab in the Second-Line Treatment of HER2-Expressing Recurrent Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-10-01

Completion Date

2028-12-31

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DRUG

RC48

Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle

DRUG

QL1706

Drug: QL1706 Iparomlimab and Tuvonralimab (QL1706) : 5 mg/kg in total, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle

Locations (1)

Qilu Hospital of Shandong University

Ji'an, Shandong, China