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A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma

NCT07131501 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-20

No results posted yet for this study

Summary

This is a single-arm, multicenter, exploratory clinical study evaluating the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection (QL1706) and lenvatinib for perioperative treatment of resectable HCC (CNLC IIb-IIIa excluding Vp3/Vp4 or CNLC Ib-IIa with high-risk recurrence factors). Eligible subjects providing written informed consent will receive study treatment. The primary endpoint is MPR rate.

Conditions

Interventions

PROCEDURE

Radical surgery

Radical surgery

PROCEDURE

TACE treatment

TACE treatment (cTACE, Idarubicin): Preoperative: 1 session; Postoperative: 1 session.

DRUG

Iparomlimab and Tuvonralimab Injection (QL1706)

Iparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W. Neoadjuvant: 2 cycles; Adjuvant: up to 17 cycles.

DRUG

Lenvatinib

Lenvatinib: 8mg (body weight \<60kg) or 12mg (body weight ≥60kg), orally (PO), once daily (QD), Q3W. Consistent daily timing. Neoadjuvant: 2 cycles.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Xuehao Wang · The First Affiliated Hospital with Nanjing Medical University

  • Yongxiang Xia · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-09-30
Completion
2029-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07131501 on ClinicalTrials.gov