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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

ConditionLiver Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhai Wenlong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. 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);

Trial design

Design model

Single group

Treatments tested in this trial

  • HAIC

    Radiation

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

  • Donafenib + lenvatinib+apatinib

    Drug

    Oraltargeted therapy administered daily

  • Sintilimab+camrelizumab+tislelizumab

    Drug

    PD--1 inhibitor administered viaintravenous infusion

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: HAIC+Targeted Therapy +PD-1 InhibitorExperimental treatment 3 interventions

Trial outcomes

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.

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.

Secondary outcomes

1

Overall survival (OS)

Overall survival (OS) is defined as the time from randomization to death from any cause. For subjects lost to follow-up before death, the time of last follow-up is generally used as the death time.

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

Other outcomes

1

Safety endpoints

Exposure to the investigational drug and the incidence, nature, and severity of adverse events (including serious adverse events) will be recorded.

Time frame
Through study completion, an average of 28 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhai Wenlong

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: