NCT03164382

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Cancer
• Hepatic Carcinoma

Interventions

Type	Name	Description
DRUG	FOLFOX regimen	Firstly, the femoral artery was percutaneously punctured using the Seldinger technique. Then, the catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography. When more than one feeding artery of HCC was detected, the smaller arteries were embolized with gelatin sponge particles. A micro-catheter was inserted through the arterial catheter located at the common hepatic artery or proper hepatic arterial branch (feeding artery). When blood flows into the gastroduodenal artery was confirmed by micro-catheter angiography, the route was embolized with a coil or micro-coil to prevent reflux of chemotherapeutic drugs to the stomach and duodenum. The peripheral part of the catheter that was exposed to the outside of the body was covered with medical sterile gauze and fastened on the thigh's skin using medical rubberized fabric and bandage. Catheter insertion was repeatedly performed before every cycle of treatment.
DRUG	Sorafenib 200Mg Tab	Sorafenib will be administered orally at the starting dose of 400 mg twice daily (800 mg total daily dose) to patients randomized to Arm S in accordance to its package insert or equivalent documentation. The 400 mg dose will be achieved by administration of 2 x 200 mg film-coated tablets, administered twice daily.

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-10-31
• Completion: 2020-11-30
• First posted: 2017-05-23
• Last updated: 2020-12-16

Locations

1 site across 1 country: China