MedTrace Logo

Oral Chemotherapy Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma

NCT01438450 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-07-13

No results posted yet for this study

Summary

Background Hepatocellular carcinoma, a malignant tumour of liver is one of the most common cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in the investigators Gastroenterology out patient department. Most of these patients present late when the disease is already advanced and no curative therapies can be offered. At this stage, palliative therapy forms the mainstay of treatment. This includes transarterial chemoembolization (TACE) or Oral chemotherapy. Many patients also have involvement of branches of portal vein, which further limit therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging of liver cancer, involvement of portal vein precludes any standard form of therapy. These patients have been recommended for experimental therapies. Various forms of chemotherapy have been tried this group of patients. HCC is a vascular tumour and thalidomide is an anti-angiogenic drug and inhibits vascularity and has been used in the treatment of HCC. Capecitabine is a novel drug, which gives continuous delivery of 5-FU and has been used in patients with HCC and has been found to be safe.

Conditions

Interventions

DRUG

Oral

Capecitabine : 500 mg OD x 1 week 500 mg BD x 1 week 500 mg (2 morning, 1 evening) x 1 week After attaining the max dose of 1500 mg, a cycle of Capecitabine 1500mg every day for 2 weeks and 1 week off to be maintained. Thalidomide: 50 mg OD x 1 week 100 mg OD x 1 week 200 mg OD x 1 week, 300 mg OD x 1 week

OTHER

Supportive

No specific therapy will be given

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Subrat K Acharya, DM · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2013-08-31
Completion
2014-09-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438450 on ClinicalTrials.gov