HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

NCT07466225 | Active Not Recruiting DMC

• 1 other identifier: CHANCE2509
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• OS

  The time from treatment initiation to death due to any cause

  From date of treatment beginning until the date of death from any cause, assessed up to 36 months.

Secondary Outcomes (5)

• PFS

  From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

• TTP

  From date of treatment beginning until the date of first documented progression, assessed up to 36 months.

• ORR

  From date of treatment beginning until the date of first documented progression disease, up to 36 months.

• DCR

  From date of treatment beginning until the date of first documented progression disease, up to 36 months.

• Number of patients with treatment-related adverse events

  From date of treatment beginning until the date of study treatment completion, up to 36 months.

Study Arms (2)

HAIC-Lenva-PD1

Received HAIC combined with Lenvatinib and PD-1 inhibitor treatment

Procedure: HAIC; Drug: Lenvatinib; Drug: PD-1 Inhibitors

Lenva-PD1

Received Lenvatinib and PD-1 inhibitor treatment

Drug: Lenvatinib 1; Drug: PD-1 inhibitors 1

Interventions

HAIC PROCEDURE

Hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.

HAIC-Lenva-PD1

Lenvatinib DRUG

12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily after HAIC.

HAIC-Lenva-PD1

PD-1 Inhibitors DRUG

PD-1 inhibitors injection intravenously or percutaneously before 24h of HAIC every 4 week

HAIC-Lenva-PD1

Lenvatinib 1 DRUG

12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily.

Lenva-PD1

PD-1 inhibitors 1 DRUG

PD-1 inhibitors injection intravenously or percutaneously every 4 week

Lenva-PD1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced HCC and portal vein/hepatic vein/inferior vena cava/bile duct tumor thrombi and treated by either HAIC+Lenva+PD1 or Lenva+PD1 from multiple centers in China

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Xiaodong Wang

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 12, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-01

Locations

CN (1)