NCT06631326Completed
HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)
Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation Study
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 244 (actual)
- First submitted
- 5 Oct 2024
- Start date
- 1 Jan 2021
- Primary completion date
- 22 Oct 2025
- Lead sponsor
- First Hospital of China Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06631326
What you commit to
- Study type: Observational
- Participants enrolled: 244
- From 1 Jan 2021 to the primary completion date, 22 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who took anti-tumor treatments before the combination therapy;
Other illness
- With other malignant tumors;
Other
- incomplete data.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.