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

Browse trials for

• Carcinoma, Hepatocellular 3,182

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 244 is above the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 59 studies on the registry; 32 are open to participants now.

Study population

Groups and cohorts

• 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

• Procedurehepatic artery infusion chemotherapy

  Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

• DrugLenvatinib + PD-1 monoclonal antibody

  PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

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.

   Time frame: Up to approximately 2 years

Secondary outcomes

1. Progression free survival(PFS) (Overall)

   The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.

   Time frame: Up to approximately 2 years

2. Progression free survival(PFS) of intra-hepatic lesions

   The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.

   Time frame: Up to approximately 2 years

3. Progression free survival(PFS) of extra-hepatic lesions

   The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.

   Time frame: Up to approximately 2 years

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

   The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT or death due to any cause, whichever occurs first.

   Time frame: Up to approximately 2 years

5. Objective response rate(ORR) per RESCIST 1.1

   The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.

   Time frame: Up to approximately 2 years

6. ORR per mRECIST

   The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.

   Time frame: Up to approximately 2 years

7. ORR of PVTT

   The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.

   Time frame: Up to approximately 2 years

8. Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0

   The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.

   Time frame: Up to approximately 2 years

Publications

• 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. PubMed 40930561 ↗

Individual participant data

Plan to share: Undecided