- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03780634
HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC
May 2, 2019 updated by: Shi Ming, Sun Yat-sen University
Hepatic Artery Infusion Chemotherapy Plus Programmed Cell Death Protein-1 (PD-1) Antibody vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma
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)
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Cancer Center Sun Yat-sen University
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Guangzhou, Guangdong, China, 510620
- Guangzhou Twelfth People 's Hospital
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Kaiping, Guangdong, China, 529300
- Kaiping Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HAIC plus PD-1 antibody
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.
|
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
200mg intravenously every 3 weeks
Other Names:
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ACTIVE_COMPARATOR: HAIC plus sorafenib
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.
|
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
400 mg Bid Po
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: 12 months
|
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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 12 months
|
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.
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12 months
|
Adverse Events
Time Frame: 12 months
|
Number of adverse events.
Postoperative adverse events were graded based on CTCAE v4.03
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12 months
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Objective Response Rate (ORR)
Time Frame: 12 months
|
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
December 18, 2018
First Submitted That Met QC Criteria
December 18, 2018
First Posted (ACTUAL)
December 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2019
Last Update Submitted That Met QC Criteria
May 2, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- Antibodies
- Sorafenib
- Immunoglobulins
Other Study ID Numbers
- HCC-S059
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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