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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Early Stage Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).

Outcome Time Frame:

1, 2, and 3 years

Safety Issue:

No

Principal Investigator

Shuqun Cheng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital

Authority:

China: Ethics Committee

Study ID:

2009PHC001

NCT ID:

NCT01055743

Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Early Stage Hepatocellular Carcinoma
  • Fluorouracil Implants
  • Hepatocellular carcinoma
  • Radical resection
  • Carcinoma
  • Carcinoma, Hepatocellular

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