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Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer

NCT07282509 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-12-15

No results posted yet for this study

Summary

This trial is an open-label, dose-escalation, and randomized controlled Phase Ib/II clinical study for second-line treatment in participants with advanced hepatocellular carcinoma (HCC). Its primary objective is to evaluate the safety, tolerability, pharmacokinetic profiles, and efficacy of transcatheter arterial infusion of HA131 combined with systemic therapy in the second-line treatment of participants with advanced HCC.

Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Interventions

DRUG

HA131

Phase Ib: Dose escalation. Phase II: Administration at the RP2D dose determined in Phase Ib. Transcatheter Arterial Infusion.

DRUG

Enlonstobart Injection

Administered via intravenous infusion.

DRUG

Pembrolizumab Injection

Administered via intravenous infusion.

DRUG

Lenvatinib Mesilate Capsules

Administered orally.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2028-06-26
Completion
2029-02-03

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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 NCT07282509 on ClinicalTrials.gov