Efficacy and safety of HAIC combined with lamvatinib in the treatment of hepatocellular carcinoma with large portal vein tumor thrombus

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045228

Enrollment

Unknown

Registered

2021-04-08

Start date

2021-05-01

Completion date

Unknown

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma with large portal vein tumor thrombus

Interventions

Control group:Lenvatinib

Experimental group:HAIC+Lenvatinib

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Diagnosis of hepatocellular carcinoma in accordance with AASLD liver cancer diagnostic guidelines; 3. No prior intra-arterial/systemic chemotherapy or other systemic therapy for HCC; 4. At least one measurable lesion according to MRECIST criteria; 5. Barcelona clinical liver cancer (BCLC) stage C; 6. Complicated with large portal vein tumor thrombus, including main portal vein tumor thrombus (VP4) and branch portal vein tumor thrombus (VP3); 7. Child-Pugh score: A or B7; 8. Physical state (PS) ECOG score 0-1; 9. Adequate organ function, defined as: (1) WBC count >= 3.0 x 10^9/L; (2) Absolute neutrophil count >= 1.5 x 10^9/L; (3) Hemoglobin (Hb) >= 8.5g/dL; (4) Platelet count >= 75 x 10^9/L; (5) Albumin >= 2.8g/dL; (6) Bilirubin <= 3.0mg/dL; (7) AST and ALT are less than 5 times the upper limit of normal; (8) Serum creatinine <= 1.5 times the upper limit of normal; 10. Subjects volunteered to participate in this study and signed the informed consent, and had good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Combined with other malignant tumors; 2. Gastrointestinal bleeding within 28 days before participating in the study; 3. The presence of gastric or esophageal varices requiring interventional therapy within 28 days of the study; 4. Allergy to lunvaltinib, fluorouracil, oxaliplatin, calcium folinate/levo folinate or iodine contrast agent is known or suspected; 5. Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except hepatitis virus); 6. To undergo major surgery within three weeks prior to this study; 7. Having received liver transplantation; 8. Patients in pregnancy or lactation; 9. Researcher consider that the patient is not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame
Objective response rate;	—

Secondary

Measure	Time frame
Progression-free survival;Overall survival;Disease control rate;Duration of relief;	—

Countries

China

Contacts

Public ContactYuan Chunwang

Beijing Youan Hospital Capital Medical University

yuancw@ccmu.edu.cn+86 18612778605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026