Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Radical resection of hepatocellular carcinoma

Radical resection

Fluorouracil Implants

Shuqun Cheng, MD

This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.

The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma

A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma

Eastern Hepatobiliary Surgery Hospital

Simcere Pharmaceutical Co., Ltd

Shuqun Cheng

Infections

Symptoms and General Pathology

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Communicable Diseases

Hepatitis A

Hepatitis C

Hepatitis

Hepatitis, Chronic

Virus Diseases

Hepatitis C, Chronic

Thrombasthenia

Disease Attributes

Hepatitis, Viral, Human

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Flaviviridae Infections

Chronic Disease

Chronic Graft Versus Host Disease

Glanzmann Thrombasthenia

Anti-Infective Agents

Ritonavir

Ribavirin

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

OBV/PTV/r (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

ombitasvir/paritaprevir/ritonavir

ribavirin

AbbVie Inc

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data after flanking imputation were imputed as nonresponders.

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ throughout treatment with at least 6 weeks of treatment.

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.

The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.

AbbVie

TEAEs and TESAEs are defined as any adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.

OBV/PTV/r ± DSV ± RBV for 12 or 24 Weeks

Age, Continuous

Sex: Female, Male

Global Medical Services

The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma	NCT01055743	Early Stage Hep...	Radical resecti... Fluorouracil Im...	18 Years - 75 Years	Simcere Pharmaceutical Co., Ltd
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma	NCT02504099	Chronic Hepatit...	ombitasvir/pari... ombitasvir/pari... ribavirin	18 Years -	AbbVie
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma	NCT01055743	Early Stage Hep...	Radical resecti... Fluorouracil Im...	18 Years - 75 Years	Simcere Pharmaceutical Co., Ltd

Spots Global Cancer Trial Database for early stage hepatocellular carcinoma