Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC
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ClinicalTrials.gov Identifier: NCT02774187 |
Recruitment Status :
Completed
First Posted : May 17, 2016
Last Update Posted : December 5, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma | Drug: Sorafenib Procedure: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 247 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Sorafenib Alone Versus Sorafenib Combined With Hepatic Arterial Chemoinfusion for Advanced HCC With Portal Vein Tumor Thrombosis: a Multicentre Randomised Controlled Trial |
Actual Study Start Date : | May 2016 |
Actual Primary Completion Date : | July 2017 |
Actual Study Completion Date : | August 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Sorafenib combined with HAIC
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
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Drug: Sorafenib
administration of Sorafenib Procedure: Hepatic arterial infusion chemotherapy administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Name: HAIC Drug: Folfox Protocol Oxaliplatin , fluorouracil, and leucovorin
Other Name: Oxaliplatin , fluorouracil, and leucovorin |
Active Comparator: Sorafenib alone
Sorafenib alone
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Drug: Sorafenib
administration of Sorafenib |
- Overall survival [ Time Frame: 6 months ]Overall survival
- Time to progression [ Time Frame: 6 months ]Time to progression
- Adverse Events [ Time Frame: 30 days ]Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
- 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 v3.0
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- portal vein tumor thrumbus confirmed in two image techniques
- Eastern Cooperative Oncology Group performance status of 0 to 2
- 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.
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774187
China, Guangdong | |
Cancer Center Sun Yat-sen University | |
Guangzhou, Guangdong, China, 510060 | |
The First Affiliated Hospital of Sun Yat-sen University | |
Guangzhou, Guangdong, China, 510060 | |
Guangzhou Twelfth People 's Hospita | |
Guangzhou, Guangdong, China, 510620 | |
The Kaiping Center's Hospital | |
Kaiping, Guangdong, China, 529300 | |
China, Hunan | |
First Affiliated Hospital of University Of South China | |
Hengyang, Hunan, China, 421001 |
Principal Investigator: | Ming Shi, MD | The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shi Ming, professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02774187 |
Other Study ID Numbers: |
HCC-S021 |
First Posted: | May 17, 2016 Key Record Dates |
Last Update Posted: | December 5, 2019 |
Last Verified: | December 2019 |
Hepatocellular Carcinoma Hepatic arterial infusion chemotherapy Sorafenib |
Carcinoma, Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Leucovorin Fluorouracil Oxaliplatin Sorafenib |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Protein Kinase Inhibitors Enzyme Inhibitors |