Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma
Condition: Liver Cancer; Hepatic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): FOLFOX regimen; Sorafenib 200Mg Tab
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment