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

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HAIC
PD-1 antibody
Sorafenib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Programmed cell death protein-1 antibody, Oxaliplatin, 5-Fluorouracil and Leucovorin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cancer Center Sun Yat-sen University
  • Guangzhou Twelfth People 's Hospital
  • Kaiping Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAIC plus PD-1 antibody

HAIC plus sorafenib

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST.
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Full Information

First Posted
December 18, 2018
Last Updated
May 2, 2019
Sponsor
Sun Yat-sen University
Collaborators
Kaiping Central Hospital, Guangzhou No.12 People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03780634
Brief Title
HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC
Official Title
Hepatic Artery Infusion Chemotherapy Plus Programmed Cell Death Protein-1 (PD-1) Antibody vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Kaiping Central Hospital, Guangzhou No.12 People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Programmed cell death protein-1 antibody, Oxaliplatin, 5-Fluorouracil and Leucovorin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAIC plus PD-1 antibody
Arm Type
Experimental
Arm 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.
Arm Title
HAIC plus sorafenib
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
HAIC
Intervention Description
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
Intervention Type
Drug
Intervention Name(s)
PD-1 antibody
Other Intervention Name(s)
Programmed cell death 1 antibody
Intervention Description
200mg intravenously every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
400 mg Bid Po
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Time Frame
12 months
Title
Objective Response Rate (ORR)
Description
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST.
Time Frame
12 months
Title
Adverse Events
Description
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangzhou Twelfth People 's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510620
Country
China
Facility Name
Kaiping Central Hospital
City
Kaiping
State/Province
Guangdong
ZIP/Postal Code
529300
Country
China

12. IPD Sharing Statement

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

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