HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
Study Details
Study Description
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 evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HAIC plus H101 Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery |
Procedure: HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Names:
Drug: H101
Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
Other Names:
|
| Active Comparator: HAIC Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery |
Procedure: HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Names:
Drug: Placebos
Patients receive normal saline 10ml in each session of HAIC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [24 months]
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Secondary Outcome Measures
- Progression free survival (PFS) [24 months]
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
- Number of adverse events [30 days]
Postoperative adverse events were graded based on CTCAE v4.03
- Conversion rate to resection [24 months]
Patients receive subsequent resection.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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No Cirrhosis or cirrhotic status of Child-Pugh class A only
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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 Criteria:
-
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Center Sun Yat-sen University | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Ming Shi, MD, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCC-S032