NCT03869034Active, not recruitingPhase 2

HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC

Hepatic Arterial Infusion Chemotherapy Combined with PD-1 Inhibitor in Treating Potentially Resectable Locally Advanced Hepatocellular Carcinoma: a Prospective, Phase II Clinical Study

Source: ClinicalTrials.gov · Last updated 3 Dec 2024

Brief summary (registry, in English)

Hepatocellular carcinoma patients are mostly diagnosed at locally advanced stage. Nowadays, hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these patients. Our previous study showed that compared to than conventional transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC) has better objective response, better safety profile, and increased resection rates. The PD-1 inhibitors emerged in recent years have shown good momentum in the treatment of hepatocellular carcinoma. The single-drug treatment on advanced hepatocellular carcinoma has a tumor response rate of 17%, the disease control rate exceeds 60%, and the overall survival time exceeds 12 months. And it has good tolerance and less adverse events. In studies of other cancer, combined with traditional chemotherapy can further improve the efficacy of PD-1 inhibitors. Our study is a prospective phase II clinical study for patients with potentially resectable locally advanced hepatocellular carcinoma (tumor confined to the liver with invasion to branches of the portal vein or hepatic vein). Progressive survival (PFS) is the primary end point of study. The OS and overall survival rate, RFS, ORR, DCR, conversion rate, pathological response, and safety are the secondary endpoints. The efficacy and safety of HAIC combined with PD-1 inhibitor in the treatment of potentially resectable locally advanced hepatocellular carcinoma will be discussed.

Status (registry): Active, not recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 40 (actual)
First submitted: 2 Mar 2019
Start date: 25 Mar 2019
Primary completion date: 20 Jul 2020
Lead sponsor: Sun Yat-sen University
Diseases: Liver and biliary tract cancer
NCT number: NCT03869034

What you commit to

Study type: Interventional · Phase 2
Participants enrolled: 40
From 25 Mar 2019 to the primary completion date, 20 Jul 2020
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> CTCAE Version 4.03 adverse events of grade 2).
History of other malignancies.
History of allergic reactions to related drugs.
History of organ transplantation.

Lab values

With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT).

Other

Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
Patients with tumor thrombus reaches or exceeds the portal vein.
Pregnant women, nursing mothers.
Patients have other factors that may interfere with patient enrollment and assessment results.
Refuse follow-up as required by this study protocol and refuse to sign informed consent.

Who the study is looking for

Age between 18 years and 70 years.
Hepatocellular carcinoma: patients need to be diagnosed as hepatocellular carcinoma (HCC) histologically before treatment.
Never received any anti-cancer treatment in the past.
potentially resectable Locally advanced HCC: with at least one measurable lesion (RECIST 1.1), and tumor(s) confined to the left or right hemi-liver, with macroscopic invasion to branch of the portal vein and/or hepatic vein.
No extrahepatic metastases.
No contraindications for the treatment of HAIC and PD-1 inhibitors.
KPS≥90.
Liver function: Child-Pugh class A.
The expected survival of the patient is more than 6 months.
Adequate hematological and organ function.
The following conditions are met:
- Platelet≥75×10\^9/L; White blood cell≥3.0×10\^9/L; Hemoglobin≥90 g/L; Serum creatinine≤1.5 × upper limit of normal (ULN); PT≤3 second extension; total bilirubin ≤1.5 x ULN； AST and ALT ≤2.5 x ULN.
Agree to accept postoperative follow-up required by the design of this study.
Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status	Guangzhou	China	Unknown status

Related publications

Hepatic arterial infusion chemotherapy plus sintilimab as conversion therapy for locally advanced hepatocellular carcinoma: a single-center phase II trial.Int J Surg · 2026 · PMID 41537370

This page is information, not medical advice. Discuss any trial with your doctor.