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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438450
Recruitment Status : Unknown
Verified July 2012 by Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : September 22, 2011
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Oral Other: Supportive Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT Of Oral Thalidomide And Capecitabine Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma (BCLC D)
Study Start Date : October 2007
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : September 2014

Arm Intervention/treatment
No Intervention: Supportive
Supportive therapy
Other: Supportive
No specific therapy will be given
Other Name: Supportive therapy

Active Comparator: Oral
Oral thalidomide and capecitabine
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 Name: Oral chemotherapy

Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Tumour response [ Time Frame: 1 year ]
  2. Number of patients with side effects [ Time Frame: 1 year ]
    Patients developing various adverse events will be recorded

  3. Quality of life [ Time Frame: 1 year ]
  4. Change from baseline in Child status at 1 year [ Time Frame: 1 year ]

    Child status is calculated from the following 5 parameters

    1. Bilirubin < 2: 1, 2-3: 2 and > 3 : 3 points
    2. Albumin: > 3.5: 1, 2.8-3.5 : 2 and <2.8: 3 points
    3. Prothrombin time( seconds over control): 1-3: 1, 4-6: 2 and > 6: 3
    4. Encephalopathy: None: 1, (grade 1 and 2): 2 and (grade 3 and 4): 3
    5. Ascites: Absent: 1, slight: 2 and moderate: 3

    Child A: score 5-6, Child B: 7-9 and Child C: 10 or more

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438450

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All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Subrat K Acharya, DM    91-112658500 ext 4934   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
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Principal Investigator: Subrat K Acharya, DM All India Institute of Medical Sciences, New Delhi
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Responsible Party: Subrat Kumar Acharya, Professor and Head, All India Institute of Medical Sciences, New Delhi Identifier: NCT01438450    
Other Study ID Numbers: ICMR- D.O No.5/8/7/26/99-ECD-1
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012
Keywords provided by Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi:
Advanced hepatocellular carcinoma
Supportive care
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases