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The protective effect of Telbivudine combined Radiotherapy for patients with primary liver cancer with hepatitis B virus infection

The protective effect of Telbivudine combined Radiotherapy for patients with primary liver cancer with hepatitis B virus infection

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001100
Enrollment
Unknown
Registered
2010-03-10
Start date
2010-02-01
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

primary liver cancer with hepatitis B virus infection

Interventions

Control group:Radiotherapy only
Experimental group:Radiotherapy combined Telbivudine

Sponsors

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 65 years old; 2. KPS>=70; 3. Definite diagnosis of liver cancer, by pathology or radiology combined serum tumor marker or functional imaging, and Definite diagnosis of hepatitis B virus infection; 4. Liver function classificaion is Child A or B; 5. Less than grade two of bone marrow suppression by routine blood test; 6. With normal renal function; 7. ALT and ALP are generally less than twice the upper limit of normal; 8. No antiviral drugs within three months; 9. Never receive radiotherapy for upper abdomen; 10. Sign written informed consent regarding treatment.

Exclusion criteria

Exclusion criteria: 1. The diagnosis of liver cancer or hepatitis B virus infection is unclear, or hepatitis B virus infection is defined; 2. Liver function classificaion is Child C; 3. Bone marrow suppression is grade two or above; 4. With abnormal renal function; 5. With active hepatitis(ALT level is more than twice the upper limit of normal); 6. Under antiviral drugs within three months; 7. Pregnant and lactation women; 8. Poor compliance or Reluctant to the trial.

Design outcomes

Primary

MeasureTime frame
Liver function 12 weeks after radiotherap;

Countries

China

Contacts

Public ContactWu Lili
wu.lili@zs-hospital.sh.cn+86 021 64041990-2763

Outcome results

None listed

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