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

Simcere

Status and phase: Unknown; Phase 2

Conditions: Early Stage Hepatocellular Carcinoma

Treatments: Procedure: Radical resection; Drug: Fluorouracil Implants

Study type: Interventional

Funder types: Other

Identifiers

NCT01055743

2009PHC001

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of stage I hepatocellular carcinoma
• Child-Pugh class A, B
• Radical resection is feasible
• Patients with adequate renal, hepatic, and hematologic function
• Written informed consent

Exclusion criteria

• Allergic to chemotherapy drugs
• No measurable lesion
• Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
• Evidence of serious infection
• Renal or hepatic dysfunction, significant cardiovascular disease
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Radical resection + Fluorouracil Implants

Experimental group

Treatment:

Drug: Fluorouracil Implants

Procedure: Radical resection

Radical resection

Active Comparator group

Treatment:

Procedure: Radical resection