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

Sponsor
Zhai Wenlong
Study ID
NCT07790419
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Aug 27, 2026
Start date
Aug 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAIC+Targeted Therapy +PD-1 Inhibitor
    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

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: 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. ]

Central Contacts

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