HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC

Sun Yat-sen University

Status and phase: Withdrawn; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: HAIC; Drug: PD-1 antibody; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT03780634

HCC-S059

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with Programmed Cell Death Protein-1 (PD-1) antibody compared with HAIC plus sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Full description

The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced hepatocellular (HCC). Programmed Cell Death Protein-1 (PD-1) antibody has been proved effective and safety for advanced HCC. There is no study about HAIC plus PD-1 antibody. Thus, the investigators carried out this prospective randomized control study to compare HAIC plus sorafenib and HAIC plus PD-1 antibody.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.

• Barcelona clinic liver cancer-stage C

• Major portal vein tumor thrombus (Vp3,Vp4)

• Eastern Cooperative Oncology Group performance status of 0 to 1

• with no previous treatment

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• Not amendable to surgical resection, local ablative therapy and any other cured treatment.

• The following laboratory parameters:

  • Platelet count ≥ 75,000/μL
  • Hemoglobin ≥ 8.5 g/dL
  • Total bilirubin ≤ 30mmol/L
  • Serum albumin ≥ 30 g/L
  • ASL and AST ≤ 5 x upper limit of normal
  • Serum creatinine ≤ 1.5 x upper limit of normal
  • INR ≤ 1.5 or PT/APTT within normal limits
  • Absolute neutrophil count (ANC) >1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion criteria

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known central nervous system tumors including metastatic brain disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

HAIC plus PD-1 antibody

Experimental group

Description:

Participants received PD-1 antibody intravenously and hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Treatment:

Procedure: HAIC

Drug: PD-1 antibody

HAIC plus sorafenib

Active Comparator group

Description:

Participants received sorafenib capsules 400mg bid in continuous 21-day treatment cycles, and received hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Treatment:

Procedure: HAIC

Drug: Sorafenib