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To compare cause specific survival in control transarterial chemotherapy and transarterial chemotherapy Plus stereotactic body radiation therapy in Hepatocelluar carcinoma

Randomized controlled trial of drug eluting beads based transarterial chemotherapy (TACE) with or without stereotactic body radiation therapy (SBRT) in patients with nonmetastatic unresectable hepatocellular carcinoma.(TACS-RT Study) - TACE-SBRT

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007161
Enrollment
386
Registered
2016-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Liver Cancer

Interventions

Intervention1: Arm 1. DEB TACE : Patient randomized to DEB TACE arm will receive 3 cycles of DEB TACE. This will involve catheterization of the feeding vessels and injecting 100 mg of doxorubicin dru

Sponsors

Tata Memorial Centre Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Diagnosis of HCC Age more than 18yrs Barcelona Stage B Barcelona A not deemed suitable for surgery or refuse surgery. Child pugh A Child pugh B score 7 out of 10 ECOG 0 to 1 Total number of measurable target lesion 2 or less than 2 Optimal predicted liver volume reserve more than 700 cc No contraindication for TACE. Willing for molecular banking of tumour tissue.

Exclusion criteria

Exclusion criteria: Exclusion Metastatic or nodal disease on staging investigations Child C Cirrhosis or previous history of liver failure Expected life span more than 6 months Active variceal bleding or orther signs of hepatic decompensation Portal venous thrombosis rendering patients unsuitable for TACE

Design outcomes

Primary

MeasureTime frame
To campare two years overall survival OAS and one year infield progression free survival PFS in control TACE and interventional TACE plus SBRT armTimepoint: two years for overall survival OAS and one year for infield progression free survival PFS respectively

Secondary

MeasureTime frame
To compare cause specific survival in control and interventionTimepoint: At study completion;To compare quality of life QOL in control and intervention armTimepoint: At study completion;To evaluate functional imaging MRI and PET characteristics predictive of therapeutic response and overall survival in patients with HCCTimepoint: At study completion

Countries

India

Contacts

Public ContactDr Supriya Chopra

Tata Memorial Centre ACTREC

schopra@actrec.gov.in912227405113

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026