Status:
UNKNOWN
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evalua...
Eligibility Criteria
Inclusion
- The diagnosis of HCC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- With no previous treatment
- Single lesion with tumor size larger 7cm or multiple lesions
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- BCLC A-B stage
- The following laboratory parameters:
- Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
Exclusion
- Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (\> grade 2 National Cancer Institute \[NCI\] -common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0) or other serious associated diseases will not be able to tolerate treatment
- With other malignant tumors
- Known or suspected allergy to the investigational agents or any agent given in association with this trial
- History of organ allograft
- Pregnant or lactating woman
- patients with poor compliance
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT03780049
Start Date
October 1 2018
End Date
October 1 2023
Last Update
May 21 2020
Active Locations (1)
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1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060