HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

NCT06631326 | Completed

• 1 other identifier: CHANCE2416
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Conditions

HCC - Hepatocellular Carcinoma; Hepatic Arterial Infusion Chemotherapy; BCLC Stage C Hepatocellular Carcinoma; Lenvatinib; PD-1 Inhibitors

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

  Up to approximately 2 years

Secondary Outcomes (8)

• Progression free survival(PFS) (Overall)

  Up to approximately 2 years

• Progression free survival(PFS) of intra-hepatic lesions

  Up to approximately 2 years

• Progression free survival(PFS) of extra-hepatic lesions

  Up to approximately 2 years

• Progression free survival(PFS) of portal vein tumor thrombus (PVTT)

  Up to approximately 2 years

• Objective response rate(ORR) per RESCIST 1.1

  Up to approximately 2 years

Study Arms (2)

HAIC plus Lenvatinib and PD-1 inhibitors

Each patient should receive at least 2 cycles of HAIC, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.

Procedure: hepatic artery infusion chemotherapy; Drug: Lenvatinib + PD-1 monoclonal antibody

Lenvatinib plus PD-1 inhibitors

Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib.

Drug: Lenvatinib + PD-1 monoclonal antibody

Interventions

hepatic artery infusion chemotherapy PROCEDURE

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

HAIC plus Lenvatinib and PD-1 inhibitors

Lenvatinib + PD-1 monoclonal antibody DRUG

PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

HAIC plus Lenvatinib and PD-1 inhibitors; Lenvatinib plus PD-1 inhibitors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with high tumor burden advanced HCC with PVTT who received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.

You may qualify if:

• Age 18 to 80 years old;
• Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
• At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
• HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
• Presence of PVTT;
• Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
• Child-Pugh class A or B7;
• Tumor burden meets up to 7 out criteria.

You may not qualify if:

• Patients who took anti-tumor treatments before the combination therapy;
• With other malignant tumors;
• incomplete data.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The first hospital of China medical university

Shenyang, Liaoning, 110000, China

Location

Related Publications (1)

• Liu J, Zhang S, Shao H. Hepatic arterial infusion chemotherapy plus lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors as first-line treatment for hepatocellular carcinoma with high tumour burden and portal vein tumour thrombus (CHANCE 2416): study protocol of a multicentre, retrospective, target trial emulation design. BMJ Open. 2025 Sep 9;15(9):e099510. doi: 10.1136/bmjopen-2025-099510.

  PMID: 40930561 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Haibo Shao

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2021
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)