Clinical Trials Logo
  1. Home
  2. Liver Cancer
  3. NCT03164382

Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma

Liver Cancer Clinical Trial

Official title:
A Phase III Randomized Trial of Comparison of Survival Benefit of Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin With Sorafenib for Patients With Barcelona-Clinic Liver Cancer (BCLC)-C Stage Hepatocellular Carcinoma

Clinical Trial Summary

This trial was designed to investigate whether the survival outcome, response rate and safety of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than those of the standard treatment with sorafenib or not.

Clinical Trial Description

Hepatocellular carcinoma is the fifth most common malignancy worldwide. Advanced-stage disease is found in 25%-70% of HCC at diagnosis, with a median survival time of only 4.2-7.9 months due to limited treatment options. To date, sorafenib is the only standard treatment shown to extend overall survival for advanced hepatocellular carcinoma (Ad-HCC). However, low response rates, modest survival advantages and high-level heterogeneity of individual response, such limitations of sorafenib prohibit its widespread use in Ad-HCC and more alternative therapies are highly required at present. Hepatic arterial infusion chemotherapy (HAIC) can provide chemotherapeutic agents to liver at higher concentration with lower toxicity and has been reported favorable results in advanced HCC. However, HAIC provides good but variable outcomes, with a response rate of 7-81% and median survival time of 6-15.9 months. The unstable response may attribute to complicate combinations based on various drugs, including fluorouracil (5-FU), cisplatin, doxorubicin, mitomycin, leucovorin and interferon. FOLFOX (oxaliplatin, 5-FU/leucovorin) was a regimen first used in colon cancer with liver metastasis and reported to be effective both by systemic and HAIC in amounts of clinical trials. A recent phase II study has shown that HAI of FOLFOX (HAIF) was well tolerated and effective in Ad-HCC. To the investigator's knowledge, no clinical studies have been developed on comparing the survival benefit of HAIF with sorafenib for patients with Ad-HCC. In this phase III trial, the investigators aimed to compare survival outcome, response rate and safety of HAIF with sorafenib in patients with Ad-HCC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03164382
Study type Interventional
Source Sun Yat-sen University
Contact
Status Completed
Phase Phase 3
Start date March 1, 2017
Completion date November 30, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Recruiting NCT05160740 - Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer N/A
Completed NCT01906021 - Study of New Software Used During Ablations N/A
Terminated NCT04589884 - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Recruiting NCT05953337 - Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC) N/A
Enrolling by invitation NCT04466124 - Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT03059238 - Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure Phase 3
Recruiting NCT02632188 - Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT01388101 - Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor) N/A
Terminated NCT00903396 - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer Phase 2
Completed NCT01042041 - Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer Phase 1
Completed NCT00980239 - HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver Phase 1
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Completed NCT00543777 - Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease Phase 1/Phase 2