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HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma

NCT06187961 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-22

No results posted yet for this study

Summary

This is an open-label, single-arm, phase 2 study evaluating hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and cadonilimab as conversion therapy for initially unresectable hepatocellular carcinoma (HCC). The primary objective is to assess the conversion rate, defined as the proportion of participants who are deemed amenable to curative-intent treatment by the multidisciplinary team (MDT), including R0 resection, curative ablation, or liver transplantation, after study treatment. Secondary objectives include curative-intent intervention rate, tumor response, survival outcomes, safety, pathological response, and exploratory tissue and blood biomarkers.

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

PROCEDURE

Hepatic arterial infusion chemotherapy (HAIC-FOLFOX)

Administration of oxaliplatin, leucovorin, and fluorouracil via the tumor-feeding hepatic artery every 3 weeks.

DRUG

Lenvatinib

Lenvatinib administered orally once daily at 8 mg for participants weighing ≤60 kg or 12 mg for participants weighing \>60 kg.

DRUG

Cadonilimab

Cadonilimab administered intravenously at 10 mg/kg every 3 weeks.

Sponsors & Collaborators

  • Akesobio

    collaborator INDUSTRY

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Ze-yang Ding, Prof. · Tongji Hospital

  • Han Dr. Gao · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06187961 on ClinicalTrials.gov