HAIC in Combination with PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)
NCT ID: NCT06631326
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
228 participants
OBSERVATIONAL
2024-09-16
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
hepatic artery infusion chemotherapy
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
Lenvatinib + PD-1 monoclonal antibody
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Lenvatinib plus PD-1 inhibitors
Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib.
Lenvatinib + PD-1 monoclonal antibody
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
hepatic artery infusion chemotherapy
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
Lenvatinib + PD-1 monoclonal antibody
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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;
3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
5. Presence of PVTT;
6. 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.
7. Child-Pugh class A or B7;
8. Tumor burden meets up to 7 out criteria.
Exclusion Criteria
2. With other malignant tumors;
3. incomplete data.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Hospital of China Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Haibo Shao
Professor, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Haibo Shao
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The first hospital of China medical university
Shenyang, Liaoning, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Haibo Shao
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHANCE2416
Identifier Type: -
Identifier Source: org_study_id