Antiviral therapy for liver cancer patients after surgery
Exploratory Study on Optimized Antiviral Strategy After Radical Resection of Hepatitis B-related Hepatocellular Carcinoma
This study is testing if a combination of antiviral treatments can help liver cancer patients feel better after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05466565 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of peginterferon α-2b combined with nucleoside analogs on patients who have undergone radical surgery for hepatitis B associated hepatocellular carcinoma. Eligible patients will be screened and divided into three treatment groups based on their therapy regimen. Data will be collected at fixed time points post-treatment initiation to assess the outcomes of the different antiviral therapies. The study will involve a total of 360 subjects from a single center.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with hepatocellular carcinoma who have undergone radical surgery and are HBsAg positive.
Not a fit: Patients currently receiving hepatotoxic drugs, immunosuppressants, or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve post-surgical outcomes for liver cancer patients by optimizing antiviral therapy.
How similar studies have performed: While similar approaches have been explored, this specific combination therapy in the post-surgical context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age: 18-65 years old, gender is not limited; 2. Patients with hepatocellular carcinoma after radical surgical resection or radiofrequency ablation; 3. HBsAg positive; 4. Intraoperative pathology showed no residual incision margin, and imaging confirmed as complete remission (CR) within 4 weeks after operation; 5. The investigator evaluates that they can receive peginterferon and nucleoside (acid) analog therapy; 6. Sign the informed consent form and be able to comply with the requirements of the program; if the patient cannot sign the informed consent form, his/her legal guardian or agent must sign it. Exclusion Criteria: * 1\. Are receiving hepatotoxic drugs, immunosuppressants or targeted drug therapy, or receiving adjuvant chemotherapy after surgery; 2. Past or concurrent with other malignant tumors, except for cured skin basal cell or squamous cell carcinoma and cervical carcinoma in situ; 3. Those who are allergic to interferon alpha and its drug components, and those who are judged by the investigator to be unsuitable for the use of interferon alpha; 4. Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug-induced liver disease, non-alcoholic fatty liver disease and other chronic liver diseases; combined with autoimmune diseases, including autoimmune liver disease, Psoriasis, etc.; 5. Neutrophil count \< 1.5 x 109 cells/L or platelet count \< 80 x 109 cells/L; 6. Creatinine is higher than 1.5 times the upper limit of normal; 7. Patients with serious diseases of the heart, lung, kidney, brain, blood and other important organs; 8. Patients with severe neurological and psychiatric diseases (such as epilepsy, depression, mania, seizures, schizophrenia, etc.); 9. Unstable control of diabetes, hypertension, thyroid disease, etc.; history of severe retinopathy or patients with retinopathy shown by other evidence; 10. Child-Pugh is graded C; 11. Drug abuse or alcoholism; 12. Infection, hemorrhage or other postoperative complications deemed unsuitable to participate in the study during the baseline examination; the baseline examination indicates the recurrence and metastasis of liver cancer; 13. Pregnant or breastfeeding women or patients who have a pregnancy plan and are unwilling to contracept during the study period; 14. The investigator believes that the subject's current condition is not suitable for participating in this study; 15. Patients who participate in other clinical research trials at the same time.
Where this trial is running
Changsha, Hunan
- Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Ledu Zhou, PhD student
- Email: zhould@csu.edu.cn
- Phone: 17373120367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.