TACE+radiotherapy versus TACE in down-staging of non-surgical locally hepatocellular carcinoma before liver resection: A clinical prospective, randomized controlled, phase II trial (GX-HCC-001)

TACE+radiotherapy versus TACE in down-staging of non-surgical locally hepatocellular carcinoma before liver resection: A clinical prospective, randomized controlled, phase II trial (GX-001)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018000

Enrollment

Unknown

Registered

2018-08-26

Start date

2018-08-26

Completion date

Unknown

Last updated

2018-09-03

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

Conditions

HCC

Interventions

Group 1:TACE+RT

Group 2:TACE

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Primary HCC was diagnosed by pathology or according to the EASL criteria of HCC: Noninvasive criteria applied to cirrhotic patients were based on imaging findings obtained by 4-phase CT scan and/or dynamic contrast-enhanced MRI, and diagnosis was established by a single imaging technique in nodules bigger than 2 cm showing radiologic hallmarks of HCC (hypervascularity in the arterial phase with washout in the portal venous or delayed phases) or with 2 coincidental techniques for nodules measuring 1 to 2 cm in diameter; 2. Non-surgical locally hepatocellular carcinoma; 3. Child-Pugh class A cirrhosis; 4. One-3 nodulars; 5. Normal liver volume > 700 ml; 6. Eastern Clinical Oncology Group (ECOG) 0, 1, or 2; 7. The survive time is expected more than 3 months; 8. Aged > 18 years; 9. Total bilirubin 28 g/L; 11. INR < 3; 12. ALT and AST not more than 3 times normal limit; 13. Creatinine < 150 umol/L; 14. Its authorized legal representative to understand and agree to sign a consent form.

Exclusion criteria

Exclusion criteria: 1. Previous history of abdominal radiotherapy; 2. Child-Pugh class B/C cirrhosis; 3. The number of lesions was more than 3; 3. Direct invasion of tumor and surrounding tissues, or perforation of gall bladder and other organs; 4. Regional lymph node metastasis or extrahepatic metastasis; 5. Normal liver volume < 700ml; 6. There are radiotherapy or TACE contraindications; 7. Severe varicocele of esophageal vein and bleeding history or the occurrence of active gastrointestinal bleeding in 2 weeks; 8. Obvious ascites and invalid clinical treatment; 9. pregnant women; 10. In the past 6 months, underwent systemic chemotherapy; 11. Other clinical trials are performed simultaneously.

Design outcomes

Primary

Measure	Time frame
Objective response rate;Surgical Excision Rate(R0);	—

Secondary

Measure	Time frame
PFS;OS;	—

Countries

China

Contacts

Public ContactTing-Shi Su

Affiliated Tumor Hospital of Guangxi Medical University

sutingshi@163.com+86 18878708186

Outcome results

None listed

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