Randomized Control Trial (RCT) of Transarterial Chemoembolization (TACE) Versus TACE and Oral Drug Therapy in the Treatment of Unresectable Hepatocellular Carcinoma
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00522405 |
Recruitment Status
: Unknown
Verified August 2007 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Recruiting
First Posted
: August 29, 2007
Last Update Posted
: July 16, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Background Hepatocellular carcinoma, a malignant tumor 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 our 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 TACE or Oral chemotherapy. Whether oral chemotherapy administered along with TACE potentiates the effect and further prolongs survival, needs to be ascertained. No studies of this kind are available.
This prospective study is therefore designed to address this issue.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Procedure: TACE | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | October 2007 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | October 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Transarterial Chemoembolisation
|
Procedure: TACE
|
Active Comparator: 2
TACE Plus oral chemotherapy
|
Procedure: TACE
|
- Survival rate- calculated from the start of TACE
- a) Tumor response on dual phase CECT b) Patient tolerance c) Childs' status of cirrhosis- will be ascertained at one and two years of follow up depending upon the Childs' scoreScore <6- Childs'A, 7-9 Childs'B and >10 Childs'C

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients above 12 years of age with performance status (PST)score of 0-2
- Unresectable HCC with underlying Child's A/B cirrhosis
- Normal Main portal vein and its branches
- Normal Inferior vena cava
- No history of drug allergy
- Informed written consent of patient.
- Less than 50% involvement of liver by HCC
Exclusion Criteria:
- Unresectable HCC with underlying Child's C cirrhosis
- Performance status 3-5
- Extrahepatic disease
- Vascular involvement
- Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
- Previous history of encephalopathy/ upper gastrointestinal bleed in the last six months
- HCC in a female of child bearing age

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 ClinicalTrials.gov identifier (NCT number): NCT00522405
Contact: Subrat K Acharya, D.M | 91-11-26588500 ext 4934 | subratacharya2004@yahoo.com |
India | |
All India Institute of Medical Sciences | Recruiting |
New Delhi, Delhi, India, 110029 | |
Sub-Investigator: Shashi B Paul, Ph.D | |
Sub-Investigator: Shivanand Gamanagatti, MD | |
Sub-Investigator: Kaushal Madan, DM | |
Sub-Investigator: Sreenivasa B Chalamalasetty, DM | |
Sub-Investigator: Sreenivas Vishnubhatla, Ph.D |
Principal Investigator: | Subrat K Acharya, DM | All India Institute of Medical Sciences, New Delhi, India |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00522405 History of Changes |
Other Study ID Numbers: |
A-39/29.1.2007 ICMR No-5/8/7/26/99-ECD-I |
First Posted: | August 29, 2007 Key Record Dates |
Last Update Posted: | July 16, 2012 |
Last Verified: | August 2007 |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
Transarterial chemoembolisation Thalidomide Capecitabine Treatment |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |