NCT07466225Active, not recruiting
HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion
Hepatic Arterial Infusion Chemotherapy Combined With Lenvatinib and PD-1 Inhibitors for Advanced Hepatocellular Carcinoma With Macrovascular or Biliary Invasion: A Multicenter, Controlled Real-World Study
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
The combination of HAIC with systemic therapy can provide superior efficacy compared to systemic therapy alone or local therapy alone for patients with advanced HCC complicated by vascular invasion, regardless of whether they have extrahepatic metastasis, with overall manageable safety. Currently, guidelines have recommended HAIC for HCC patients with unresectable primary tumors, PVTT type I/II/III/IV, and Child-Pugh A liver function, and recognize that its combination with sorafenib for patients with PVTT has superior efficacy compared to sorafenib monotherapy. However, more evidence is still needed regarding the efficacy of HAIC combined with lenvatinib and PD-1 inhibitors for patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion. This study aims to further validate the efficacy and safety of lenvatinib and PD-1 inhibitors ± HAIC for HCC patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion through larger sample size multicenter real-world data, with the goal of providing new evidence-based guidance for HCC treatment in clinical practice. This study is to evaluate the efficacy and safety of HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib combined with PD-1 inhibitors in the first-line treatment of advanced hepatocellular carcinoma with major vascular or biliary invasion
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 29 May 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Peking University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07466225
What you commit to
- Study type: Observational
- Planned participants: 150
- From 29 May 2026 to the primary completion date, 30 Dec 2026
- 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
- Previous systemic therapy for HCC (including immune checkpoint inhibitors, tyrosine kinase inhibitors, anti-VEGF antibodies, etc.) and hepatic arterial chemotherapy;
- Received radiotherapy and other local treatments besides HAIC during treatment;
- Received other antitumor drug therapy during treatment;
- Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components by histology/cytology;
- Previously diagnosed with any other malignancy, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ that has been curatively treated;
Other
- Incomplete outcome data or missing key baseline characteristic data.
Who the study is looking for
- Age: 18-80 years, both genders;
- Diagnosed with hepatocellular carcinoma according to the Primary Liver Cancer Diagnosis and Treatment Guidelines (2019 edition) or pathological diagnosis;
- BCLC stage C with portal vein/hepatic vein/inferior vena cava/bile duct invasion, with or without extrahepatic metastasis;
- At least one measurable intrahepatic lesion according to RECIST 1.1 criteria;
- Received first-line lenvatinib + PD-1 inhibitor combination therapy or HAIC + lenvatinib + PD-1 inhibitor combination therapy between January 2020 to June 2024;
- ECOG PS score 0-1;
- Child-Pugh score: Class A or B (≤7); ALBI score: Grade 1-2.
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 |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.