Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fuDrug: HAIC of 130 mg/m² Oxaliplatin, and 5-fuDrug: TKI
- Registration Number
- NCT04687163
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
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KPS≥70;
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The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
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Patients must have at least one tumor lesion that can be accurately measured;
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With vascular invasion or extrahepatic metastasis
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Diagnosed as unresectable with consensus by the panel of liver surgery experts;
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No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
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No Cirrhosis or cirrhotic status of Child-Pugh class A only
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Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
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Ability to understand the protocol and to agree to and sign a written informed consent document.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- 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.
- Evidence of bleeding diathesis.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OXA 85 HAIC of 85 mg/m² Oxaliplatin, and 5-fu Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu OXA 130 HAIC of 130 mg/m² Oxaliplatin, and 5-fu Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu OXA 85 TKI Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu OXA 130 TKI Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
- Primary Outcome Measures
Name Time Method Overall survival 24 months
- Secondary Outcome Measures
Name Time Method progression-free survival 24 months time to response 12 months time to the date that patients achieved objective response
Adverse Events 30 Days after HAIC objective response rate 6 months
Trial Locations
- Locations (3)
Guangzhou Twelfth People 's Hospita
🇨🇳Guangzhou, Guangdong, China
Cancer Center Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Kaiping Central Hospital
🇨🇳Kaiping, Guangdong, China