HAIC Using Oxaliplatin Plus Fluorouracil/Leucovorin for Patients With Locally Advanced HCC

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A large proportion of Asian patients with HCC present with locally advanced or metastatic disease,at which point they are ineligible for curative treatments.Oxaliplatin plus fluorouracil/leucovorin intravenous infusion was proved effective in prolonging progression-free survival(PFS) than doxorubicin as palliative chemotherapy in patients with advanced HCC from Asia. Besides, hepatic arterial infusion chemotherapy (HAIC）is a widely used method for primary or metastasis liver tumor with high local tumor response. To our knowledge, there have not been any prospective studies to assess the safety and effecacy of HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.Thus,the purpose of this phase 2 study was to assess the safety and effecacy of HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ming Zhao
• Treatments: Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• No extrahepatic spread on imaging, and filfill one of them as follows: 1.multiple HCC lesions,> 5.0 cm in diameter;2.Portal venous hepatic vein/tumor thrombus or arteriovenous/portal fistula;3.Direct invasion adjacent organs except gallbladder or penetrate the peritoneum;4.diffuse HCC.

• Eastern Cooperative Oncology Group Performance Status 0-2

• Child-Pugh Stage A or B

• At least one evaluable intrahepatic target lesions

• Previous accept sorafenib but stoped for more than 4 weeks because of disease progression or intolerance to sorafenib or refused to recieved sorafenib

• Stoped for more than 4 weeks after local treatments(surgical resection, radiofrequency ablation, transcatheter arterial chemoembolization) of tumor if presence

• Sign the informed consent.

Exclusion Criteria:

• Ever received oxaliplatin or fluorouracil/leucovorin;

• A platelet counts of > 60,000/mm3, prothrombin time activity <40%;

• Albumin <2.8 g/dL, total bilirubin ≥51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）≥5 times of upper limit

• Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;

• Severe heart, brain or kidney diseases

• Previous or concurrent cancer that is distinct in primary site or histology from HCC

• Pregnant women or lactating women;

• Allergy to fluorouracil, oxaliplatin, leucovorin calcium or iodine contrast agent.