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A phase II clinical trail to study the efficacy and safety of the stereotactic body radiotherapy for unresectable hepatocellular carcinoma>10cm

A phase II clinical trail to study the efficacy and safety of the stereotactic body radiotherapy for unresectable hepatocellular carcinoma>10cm

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-16010155
Enrollment
Unknown
Registered
2016-12-15
Start date
2016-12-14
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

HCC

Interventions

HCC>10cm: stereotactic body radiation therapy

Sponsors

Guangxi Traditional Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis was confirmed by pathology or according to the international guidelines on the EASL management of HCC; 2. Child-Turcotte-Pugh(CTP)class A or B; 3. single tumor lesions is more than 10cm; 4. the liver volume wihout irradiated was more than 700ml; 5. Piantie is unfeasible, difficult or refusal to undergo surgery or percutaneous ablative therapies; 6. Clinical Oncology Group Eastern (ECOG) score of 0, 1 or 2; 7. The overall survive is expected more than 3 months; 8. Aged more than 18 years; 9. Total bilirubin umol/L 28g/L; 11. INR<3; 12. ALT and AST do not exceed 3 times of the upper limitation; 13. creatinine <150umol/L; 14. Sign the informed consent form before joining into this study.

Exclusion criteria

Exclusion criteria: 1. Previous radiation therapy of upper abdominal; 2. CTP class C;CTP class A and B, diameter is smaller than 10cm; 3. Portal vein tumor thrombus or inferior vena cava tumor thrombus; 4. Tumor direct invasion and surrounding tissue, or cause gallbladder, other organs perforation; 5. Regional lymph node metastasis or extrahepatic metastasis; 6. No irradiation liver volume < 700ml; 7. There are radiation therapy taboo; 8. Severe esophageal varices and bleeding history or active gastrointestinal hemorrhage befor 2 weeks; 9. Obvious ascites and clinical treatment is invalid; 10. Pregnant women; 11. Systemic chemotherapy in the past six months; 12. Join other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
Overall survival rate;

Countries

China

Contacts

Public ContactTing-Shi Su

Rui Kang Hospital, Guangxi Traditional Chinese Medical University

sutingshi@163.com+86 18878708186

Outcome results

None listed

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