NCT01438450

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

5.8 years

First QC Date

September 14, 2011

Last Update Submit

July 12, 2012

Conditions

Hepatocellular Carcinoma

Keywords

ThalidomideCapecitabineAdvanced hepatocellular carcinomaTherapySupportive care

Outcome Measures

Primary Outcomes (1)

  • Survival

    1 year

Secondary Outcomes (4)

  • Tumour response

    1 year

  • Number of patients with side effects

    1 year

  • Quality of life

    1 year

  • Change from baseline in Child status at 1 year

    1 year

Study Arms (2)

Supportive

NO INTERVENTION

Supportive therapy

Other: Supportive

Oral

ACTIVE COMPARATOR

Oral thalidomide and capecitabine

Drug: Oral

Interventions

OralDRUG

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

Also known as: Oral chemotherapy
Oral
SupportiveOTHER

No specific therapy will be given

Also known as: Supportive therapy
Supportive

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above 12 years of age with
  • ECOG performance status (PST) score of 3 or above
  • Underlying Child's A and B cirrhosis
  • More than 50% involvement of liver by tumor
  • Thrombosed main portal vein
  • HV/IVC thrombosis
  • Extra hepatic disease
  • Metastatic disease
  • Informed written consent of patient

You may not qualify if:

  • History of drug allergy
  • Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
  • Pregnancy
  • Outstation patients from distant areas not in a position to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Drug TherapyPalliative Care

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Subrat K Acharya, DM

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 22, 2011

Study Start

October 1, 2007

Primary Completion

August 1, 2013

Study Completion

September 1, 2014

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

IN(1)