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Randomized controlled trial of nucleot(s)ide analogues treatment for postoperative HBV-related HCC

Randomized controlled trial of nucleot(s)ide analogues treatment for postoperative HBV-related HCC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000172
Enrollment
Unknown
Registered
2008-11-08
Start date
2007-07-01
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

Control group:Regular integrated postoperative therapy
Antiviral treatment group:Antiviral therapy (Lamivudine (100 mg/day) (GlaxoSmithKline, Beijing, China) was used as of choice antiviral treatment. Adefovir dipivoxil (10 mg/day) (GlaxoSmithKline) plus

Sponsors

Eastern Hepatobiliary Hospital, Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with aged 18 to 70 years old; 2. Patients are diagnosed with HBV-related HCC and not previously treated with anti-tumoral agents. HCC was defined on the basis of ultrasound, CT, or MRI characteristics and AFP, and was confirmed by histopathology; 3. They have serum HBV DNA of > 500 copies/ml and Child-Pugh of grade A or B; 4. They received radical hepatectomy for the initial treatment of HCC. Resected tumors were subjected to pathological examination for tumor-free resection margin > 1 cm without evidence of cancer metastasis; 5. They have no intrahepatic metastasis and extrahepatic metastasis; 6. They have no apparent abnormality of the heart, lung, and kidney; 7. They have given a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients have received antitumoral treatments or antiviral treatments within 1 year before surgery; 2. Patients unwilling to give informed consent or complete the study for other reasons; 3. Patients who are participating in other trials; 4. Pregnant or breast-feeding women or possible to conceive again; 5. Patients with psychological disorders, cardiac dysfunction, uncontrolled infection, uncontrolled peptic ulcer, metabolic disturbance, diabetes, cancers of other histotypes, distant metastasis of HCC, renal dysfunction, and other life-threatening diseases; 6. Patients who had history of malignancy or metastatic tumor of other origin in last 5 years; 7. Patients co-infected with HCV, HIV, or syphilis.

Design outcomes

Primary

MeasureTime frame
Liver function, blood routine, AFP, B ultrasound, HBVDNA, CT or MRI;

Countries

China

Contacts

Public ContactShuqun Cheng, Nan Li
chengshuqun@yahoo.com.cn+86 0 13901746139

Outcome results

None listed

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