Last updated: June 8, 2023
Sponsor: Sun Yat-sen University
Overall Status: Completed
Phase
3
Condition
Liver Cancer
Digestive System Neoplasms
Carcinoma
Treatment
TACE Drug Protocol
Hepatic arterial infusion chemotherapy
Folfox Protocol
Clinical Study ID
NCT02973685
HCC-S023
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age range from 18-75 years;
- KPS≥70;
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the EuropeanAssociation for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLCB based on Barcelona Clinic Liver Cancer staging system.
- Patients must have at least one tumor lesion that can be accurately measured;
- The sum of diameters of all lesions longer than 10 cm with the maximum lesion longerthan 7 cm.
- Diagnosed as unresectable with consensus by the panel of liver surgery experts;
- Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
- No past history of 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 consentdocument.
Exclusion
Exclusion Criteria:
- Patients with clinically significant gastrointestinal bleeding within 30 days prior tostudy entry.
- Known of serious heart disease which can nor endure the treatment such as cardiacventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding orhepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given inassociation with this trial.
- Evidence of bleeding diathesis.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose ofstudy drug
- 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.
Study Design
Total Participants: 315
Treatment Group(s): 4
Primary Treatment: TACE Drug Protocol
Phase: 3
Study Start date:
October 01, 2016
Estimated Completion Date:
November 28, 2020
Study Description
Connect with a study center
Dongguan People's Hospital
Dongguan, Guangdong 523059
ChinaSite Not Available
The First People's Hospital of Foshan
Foshan, Guangdong 510060
ChinaSite Not Available
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong 510060
ChinaSite Not Available
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong 510620
ChinaSite Not Available
Kaiping Central Hospital
Kaiping, Guangdong 529300
ChinaSite Not Available
The First Affiliated Hospital of University Of South China
Hengyang, Hunan 421001
ChinaSite Not Available
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shanxi 710061
ChinaSite Not Available
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