Transarterial Chemotherapy Compared With Oral Chemotherapy in the Treatment of Advanced Hepatocellular Carcinoma

NCT02240771 | Unknown Phase 2 DMC

• 1 other identifier: TAC-HCC
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at presentation and hence are unsuitable for the available curative treatment options. In such patients the treatment options are mainly palliative. Transarterial chemoembolization (TACE), transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only available options currently. Many patients have more advanced disease with the involvement of branches of portal vein. This further limits the therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any standard form of therapy. TAC and oral chemotherapy has been tried in this group of patients by few researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for advanced stage (BCLC C) needs to be explored. However, there are no randomized controlled trials (RCT's) available. TAC is the procedure for treating patients of HCC with portal vein invasion where only the chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent embolization of the feeding vessels. In order to select a modality which would produce better outcomes in advanced HCC patients (BCLC C), this study was planned.

Conditions

Hepatocellular Carcinoma

Keywords

Transarterial chemotherapy; Thalidomide; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Survival rate-

  Survival rate to be calculated from the start of Transarterial chemotherapy

  1 year

Secondary Outcomes (1)

• Tumor response

  1 year

Study Arms (2)

Transarterial chemotherapy

ACTIVE COMPARATOR

Doxorubicin 50mg, Cisplatin 100mg

Procedure: Transarterial chemotherapy

Oral chemotherapy

PLACEBO COMPARATOR

Thalidomide---50-300mg once a day Capecitabine---- 500-1500mg once a day

Drug: Oral chemotherapy

Interventions

Transarterial chemotherapy PROCEDURE

Femoral artery would be punctured at the upper thigh using 18 gauge needle under local anesthesia. Catheterization of the hepatic artery feeding the tumor would be done and placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered. Mixture would be prepared by using Doxorubicin 50mg and Cisplatin 100mg. Hydrocortisone 100mg and augmenting dose of analgesic and sedative would be injected prior to the administration of the drug. The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-leur lock syringes.

Also known as: TAC

Transarterial chemotherapy

Oral chemotherapy DRUG

Drugs used would be Thalidomide and Capecitabine in the following dosage schedule- Thalidomide---50mg once a day (OD) for 7 days, increased to 100mg OD for 7 days, 200mgOD for 7 days further increased to 300 mg OD. Capecitabine---- 500mg OD for 7 days, then 1000mg OD for next 7 days, increased to a maximum dose of 1500mg OD Maintenance dose - Capecitabine 1500 mg - every alternate week Thalidomide - 300 mg OD. Total leucocyte count \& Platelet count would be monitored every 15 days

Also known as: OC

Oral chemotherapy

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 12 years of age with performance status (PST) score of 0-2
• Unresectable HCC with underlying Child's A/B cirrhosis
• Blocked Main portal vein
• No history of drug allergy
• Informed written consent of patient.

You may not qualify if:

• Child's C cirrhosis
• Performance status 3-5
• Extra hepatic disease
• 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
• Pregnancy

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

AII India Institute of Medical Sciences

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

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Subrat K Acharya, D.M

  All India Institute of Medical Sciences, New Delhi, India

  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 & Head

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: September 16, 2014
• Study Start: January 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

IN (1)