- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03468231
HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC
March 11, 2018 updated by: Shi Ming, Sun Yat-sen University
Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT).
Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT.
However, HAIC of fluorouracil is not such for advanced HCC.
Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial.
Thus, the investigators carried out this prospective randomized control study to find out it.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: RongPing Guo, MD
- Phone Number: (8620)-87342266
- Email: guorp@sysucc.org.cn
Study Contact Backup
- Name: Ming Shi, MD
- Phone Number: (8620)-87343938
- Email: shiming@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Dongguan, Guangdong, China, 523059
- Recruiting
- Dongguan People's Hospital
-
Contact:
- Wusheng Yu, MD
- Phone Number: 13827285010
- Email: yuwusheng1998@126.com
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Cancer Center Sun Yat-sen University
-
Contact:
- Ming Shi, MD
- Phone Number: 86-2087343115
- Email: shiming@mail.sysu.edu.cn
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- The First Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Guosheng Tan, MD
- Phone Number: 13725254145
- Email: tgs1976@163.com
-
Guangzhou, Guangdong, China, 510620
- Recruiting
- Guangzhou Twelfth People 's Hospital
-
Kaiping, Guangdong, China, 529300
- Recruiting
- Kaiping Central Hospital
-
-
Hunan
-
Hengyang, Hunan, China, 421001
- Recruiting
- First Affiliated Hospital of University of South China
-
Contact:
- Xiaoping Wu, MD
- Phone Number: 13975486015
- Email: wxp19730806@sina.com
-
-
Shanxi
-
Xi'an, Shanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Xin Zheng, MD
- Phone Number: 13649265446
- Email: 183421344@qq.com
-
-
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.
- diagnosed with major or main portal vein invasion (Vp3 or Vp4)
- KPS≥70;
- 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.
- 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
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sorafenib plus HAIC of FOLFOX
Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin
|
Oral Sorafenib, 400mg, Bid
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Names:
|
Experimental: Sorafenbi plus HAIC of OXA
Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin
|
Oral Sorafenib, 400mg, Bid
administration of Oxaliplatin via the tumor feeding arteries
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 10 months
|
Overall survival
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 30 days
|
Number of adverse events.
Postoperative adverse events were graded based on CTCAE v4.0
|
30 days
|
Progress free survival
Time Frame: 10 months
|
Progress free survival
|
10 months
|
Number of of Patients developed Adverse Events
Time Frame: 30 days
|
Number of of patients who developed adverse event.
Postoperative adverse events were graded based on CTCAE v4.0
|
30 days
|
Tumor response
Time Frame: 10 months
|
overall response
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 9, 2018
Primary Completion (Anticipated)
September 9, 2019
Study Completion (Anticipated)
March 9, 2020
Study Registration Dates
First Submitted
March 11, 2018
First Submitted That Met QC Criteria
March 11, 2018
First Posted (Actual)
March 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 16, 2018
Last Update Submitted That Met QC Criteria
March 11, 2018
Last Verified
March 1, 2018
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
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Protein Kinase Inhibitors
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Sorafenib
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- HCC-20180309
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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