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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC plus H101 | Experimental | Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery |
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| HAIC | Active Comparator | Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC of FOLFOX | Procedure | administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | 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. | 24 months |
| Number of adverse events |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Shi, MD | Contact | +862087343938 | shiming@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Shi, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| H101 | Drug | Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC |
|
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| Placebos | Drug | Patients receive normal saline 10ml in each session of HAIC |
|
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Postoperative adverse events were graded based on CTCAE v4.03 |
| 30 days |
| Conversion rate to resection | Patients receive subsequent resection. | 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |