TACE vs TACE+SBRT for Unresectable Hepatocellular Cancer

Last updated: April 25, 2022
Sponsor: Tata Memorial Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Digestive System Neoplasms

Primary Biliary Cholangitis

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT02794337
TMC IEC III 91
  • Ages > 18
  • All Genders

Study Summary

Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable disease. In the last decade results of randomized trials and a subsequent metaanalyses established transarterial chemoembolization (TACE) or systemic chemotherapy (sorafenib) as standard of care. However, TACE alone is not a curative approach. The two year survival following TACE ranges from 31-63% with almost 100% patients developing disease progression after treatment. There is need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent metaanalyses concluded that addition of high dose radiation to TACE results in 10-35% improvement in two year overall survival. However as results of metaanalyses were based on studies with small sample size, unclear randomization procedure and heterogenous dose of radiation, the need for conducting a high quality randomized study was highlighted The present study is designed to investigate the role of high dose conformal radiation as consolidation therapy after TACE in patients with nonmetastatic unresectable HCC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of HCC. Tissue diagnosis is not mandatory however desirable. In the absenceof tissue diagnosis imaging findings characteristic of HCC will be used. i.e. in highrisk population a nodule with arterial phase enhancement and wash out duringportovenous phase will be considered as diagnostic of HCC. In patients where oneimaging is not conclusive another imaging modality will be used. However if secondimaging is also inconclusive and Alpha Feto Protein (AFP) is within the nondiagnosticor borderline range than tissue diagnosis will be deemed mandatory.
  • Barcelona Stage B/ Barcelona A not deemed suitable for Sx or refuse surgery. ChildPugh A/Select Child Pugh B (score7/10).
  • Eastern Cooperative Oncology Group Performance Status 0-1.
  • Total number of measurable target lesions 2 or less than 2, can be encompassed withina single hepatic field or 2 different hepatic fields without exceeding safe dose limitconstraints.
  • Optimal predicted liver volume reserve >700 cc. No Contraindication for TACE. Tumorconsidered to be sufficiently away from GI structures to deliver safe radiation dose (>1 cm).
  • Willing for molecular banking of tumour tissue (optional).

Exclusion

Exclusion Criteria:

  • Metastatic or nodal disease on staging investigations.
  • Child C Cirrhosis or previous history of liver failure. Expected life span <6 months.
  • Active variceal bleeding or other signs of hepatic decompensation.
  • Portal venous thrombosis rendering patients unsuitable for TACE. However if pt issuitable for superselective TACE then can be considered for trial inclusion.

Study Design

Total Participants: 67
Study Start date:
December 01, 2014
Estimated Completion Date:
January 31, 2024

Study Description

Resection or liver transplant is the only curative treatment in patients with hepatocellular carcinoma (HCC) however a vast majority of patients present with unresectable disease. In the last decade results of randomized trials and a subsequent metaanalyses established transarterial chemoembolization (TACE) as standard of care in patients with Barcelona Clinic Liver Cancer (BCLC) stage B. However, TACE alone is not a curative approach. The two year survival following TACE ranges from 31-63% with almost 100% patients developing disease progression after treatment. There is need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent metaanalyses including 17 trials (5 randomized and 12 non randomized studies) concluded that addition of high dose radiation to TACE results in upto 10-35% improvement in two year overall survival. However as results of metaanalyses were based on studies with small sample size, unclear randomization procedure and heterogenous dose of radiation, the need for conducting a high quality randomized study was highlighted. The present study is designed to investigate the role of high dose conformal radiation as consolidation therapy after TACE in patients with nonmetastatic unresectable HCC.

With an integrated phase II/III design the study investigates the impact of local radiation therapy on infield progression free survival in patients with locally advanced unresectable HCC.

Connect with a study center

  • Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre

    Navi Mumbai, Maharashtra 410210
    India

    Active - Recruiting

  • Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre

    Navi Mumbai, Maharashtra 410210
    India

    Active - Recruiting

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