Status:
UNKNOWN
Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable h...
Detailed Description
Resection is the long-term therapeutic option for resectable hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect and high relapse rate of resection for patients ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL;
- Tumor burden beyond Milan criteria
- Diagnosed as resectable with consensus by the panel of liver surgery experts;
- No past history of resection, radiofrequency ablation, TACE, TAI, 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 Criteria;
- 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
- Serious non-healing wound, ulcer, or bone fracture
- Known central nervous system tumors including metastatic brain disease
- Poor compliance that can not comply with the course of treatment and follow up.
Exclusion
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2023
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT03469479
Start Date
March 2 2018
End Date
March 2 2023
Last Update
August 2 2018
Active Locations (7)
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1
Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
2
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
3
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
4
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, China, 510620