Status:
UNKNOWN
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
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- KPS≥70;
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- Patients must have at least one tumor lesion that can be accurately measured;
- With vascular invasion or extrahepatic metastasis
- Diagnosed as unresectable with consensus by the panel of liver surgery experts;
- No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- 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;
- Ability to understand the protocol and to agree to and sign a written informed consent document.
Exclusion
- 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
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04687163
Start Date
December 30 2020
End Date
December 1 2022
Last Update
January 13 2021
Active Locations (3)
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1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
2
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China, 510620
3
Kaiping Central Hospital
Kaiping, Guangdong, China, 529300