- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03782831
TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC
April 30, 2019 updated by: Shi Ming, Sun Yat-sen University
Transarterial Chemoembolization Plus Programmed Cell Death Protein-1 Antibody Versus Transarterial Chemoembolization Alone for Unresectable Hepatocellular Carcinoma
The purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with programmed cell death protein-1 (PD-1) antibody compared with TACE Alone in patients with unresectable hepatocellular carcinoma (HCC)
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Transarterial chemoembolization (TACE) is the first-line treatment for patients with unrestable hepatocellular carcinoma (HCC) at intermediate-stage.
Programmed cell death protein-1 (PD-1) antibody is effective and safe for advanced HCC.
No study has compared the efficacy and safety of TACE plus PD-1 antibody and TACE alone.
Thus, the investigators carried out this prospective randomized control study to find out it.
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:
- KPS≥70;
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
- Patients must have at least one tumor lesion that can be accurately measured;
- Diagnosed as unresectable with consensus by the panel of liver surgery experts;
- Re commanded treated by TACE with consensus by the panel of liver MDT;
- No past history of TACE, chemotherapy or molecule-targeted treatment;
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) 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:
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- 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.
- Evidence of bleeding diathesis.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Known central nervous system tumors including metastatic brain disease
- Poor compliance that can not comply with the course of treatment and follow up.
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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TACE plus PD-1 antibody
Patients received hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA) on demand.
In addition, patients received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
|
3mg/kg intravenously every 2 weeks
Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).
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Active Comparator: TACE alone
Patients received hepatic intra-arterial infusion with lipiodol mixed with hemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA) on demand.
In addition, patients received placebos intravenously every 2 weeks
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Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).
intravenous injection every 2 weeks
Other Names:
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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 modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 mRECIST.
CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions.
PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
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12 months
|
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.
|
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
|
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 (Actual)
December 11, 2018
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
December 19, 2018
First Submitted That Met QC Criteria
December 19, 2018
First Posted (Actual)
December 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 2, 2019
Last Update Submitted That Met QC Criteria
April 30, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC-S066
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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