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A Single-center, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Regorafenib in the Treatment of Advanced Second-line or Above Hepatocellular Carcinoma

NCT07115550 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-11

No results posted yet for this study

Summary

This study is a prospective, single-center, phase II clinical trial designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) combined with regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have received at least one prior line of systemic therapy. The trial employs a single-arm design.

Study endpoint

Primary endpoint:

ORR

Secondary endpoint:

DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Iparomlimab and Tuvonralimab Injection (QL1706) in combination with Regorafenib

Iparomlimab and Tuvonralimab Injection (QL1706) in combination with Regorafenib

Sponsors & Collaborators

  • Huai'an First People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2027-08-26
Completion
2028-08-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115550 on ClinicalTrials.gov