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

NCT03780634 | Withdrawn Phase 2 DMC

• 1 other identifier: HCC-S059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy; Programmed cell death protein-1 antibody; Oxaliplatin, 5-Fluorouracil and Leucovorin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), or date of death, whichever occurred first.

  12 months

Secondary Outcomes (3)

• Overall Survival (OS)

  12 months

• Objective Response Rate (ORR)

  12 months

• Adverse Events

  12 months

Study Arms (2)

HAIC plus PD-1 antibody

EXPERIMENTAL

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.

Procedure: HAIC; Drug: PD-1 antibody

HAIC plus sorafenib

ACTIVE COMPARATOR

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.

Procedure: HAIC; Drug: Sorafenib

Interventions

HAIC PROCEDURE

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

HAIC plus PD-1 antibody; HAIC plus sorafenib

PD-1 antibody DRUG

200mg intravenously every 3 weeks

Also known as: Programmed cell death 1 antibody

HAIC plus PD-1 antibody

Sorafenib DRUG

400 mg Bid Po

HAIC plus sorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator

Study Sites (3)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Twelfth People 's Hospital

Guangzhou, Guangdong, 510620, China

Location

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

spartalizumab; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ming Shi, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: May 6, 2019

Record last verified: 2019-03

Locations

CN (3)