HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion (NCT07466225) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion
China150 participantsStarted 2026-05-29
Plain-language summary
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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* Incomplete outcome data or missing key baseline characteristic data.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
OS
Timeframe: From date of treatment beginning until the date of death from any cause, assessed up to 36 months.