A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion

NCT07790419 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-KY-2003-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion

Conditions

Liver Cancer

Keywords

HAIC

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented tumor recurrence, metastasis, or death from any cause, whichever occurs first.

  From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months.

Secondary Outcomes (1)

• Overall survival (OS)

  From the date of randomization until death from any cause, assessed up to 28 months.

Other Outcomes (1)

• Safety endpoints

  Through study completion, an average of 28 months.

Study Arms (1)

HAIC+Targeted Therapy +PD-1 Inhibitor

EXPERIMENTAL

Hepatic arterial infusion chemotherapy (HAIC): to be performed within 4-8 weeks after liver cancer surgery, as follows: Oxaliplatin 65 mg/m², IA (intra-arterial), Day 1, 0-5 hours: 5-FU 1200 mg/m², IA, maintained for 23 hours. After catheter removal, a pressure dressing for hemostasis for 6-12 hours is sufficient before discharge. The above HAIC treatment will be repeated every 3-4 weeks for a total of 2 cycles. Targeted drugs: Including lenvatinib: oral administration according to body weight; body weight ≥60 kg, 8-12 mg QD; body weight \<60 kg, 4-8 mg QD; donafenib: 80 mg BID; apatinib: 250 mg QD. The above targeted drugs will be appropriately adjusted according to the patient's tolerance to toxic side effects. PD-1 inhibitors : sintilimab 200 mg Q3W, ivgtt; camrelizumab 200 mg Q3W, ivgtt; tislelizumab 200 mg Q3W, ivgtt. This study will follow participants for disease recurrence and disease-free survival for at least 2 years. After all participants complete treatment or the

Radiation: HAIC; Drug: Donafenib + lenvatinib+apatinib; Drug: Sintilimab+camrelizumab+tislelizumab

Interventions

HAIC RADIATION

Oxaliplatin and 5-Fluorouracil（5-FU）administeredvia hepatic artery infusion

HAIC+Targeted Therapy +PD-1 Inhibitor

Donafenib + lenvatinib+apatinib DRUG

Oraltargeted therapy administered daily

HAIC+Targeted Therapy +PD-1 Inhibitor

Sintilimab+camrelizumab+tislelizumab DRUG

PD--1 inhibitor administered viaintravenous infusion

HAIC+Targeted Therapy +PD-1 Inhibitor

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years, male or female;
• Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;
• Microvascular invasion (MVI) grade ≥ 1
• No other history of tumors and no preoperative anticancer treatment.
• ECOG: 0-1;
• Baseline blood count tests and blood biochemistry must meet the following criteria:
• Hemoglobin ≥80 g/L;
• Absolute neutrophil count ≥1.5×109/L;
• Platelet count ≥50×109/L;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN);
• Total bilirubin ≤3 times ULN;
• Serum creatinine ≤1.5 times ULN;
• Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s;
• International normalized ratio (INR) ≤2.3
• Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends;

You may not qualify if:

• \. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);
• \. Pregnancy or lactation;
• \. Over 80 years old;
• \. Prior systemic chemotherapy or radiotherapy;
• \. Concomitant malignant pleural effusion or ascites;
• \. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
• \. Concomitant infection requiring anti-infective treatment;
• \. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;
• \. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
• \. Uncorrectable coagulation disorders;
• \. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension;
• \. History of myocardial infarction within 12 months, or cardiac function class III or IV;
• \. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;

Sponsors & Collaborators

• Zhai Wenlong: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

donafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Wenlong Zhai, MD

CONTACT

+86-371-66862231; ven0371@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Porfessor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 27, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)