An open, single arm, multicenter phase II clinical trail to study the efficacy and safety of the stereotactic body radiotherapy for unresectable hepatocellular carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIC-16008233

Enrollment

Unknown

Registered

2016-04-07

Start date

2014-01-01

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

hepatocellular carcinoma

Interventions

HCC:SBRT

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 less than 10cm, When the number of not more than 3, and the sum of diameter is less 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. The age is 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, the number of lesions more than 3 or sum diameter is more 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

Measure	Time frame
OS;	—

Secondary

Measure	Time frame
PFS;LC;	—

Countries

China

Contacts

Public ContactTingshi 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: Mar 7, 2026