Antiviral Therapy for Patients With Liver Cancer After Surgery

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    360
  • sponsor
    Xiangya Hospital of Central South University
Updated on 24 July 2022
cancer

Summary

This is a single-center, prospective, observational, real world study designed to evaluate the effects of peginterferon α-2b(pegabin) combined with nucleoside (acid) analogs (entecavir,ETV tenofovir,TDF tenofovir alafenamide,TAF) on patients after radical surgery for hepatitis B associated hepatocellular carcinoma by collecting data from patients at our hospital

Description

In this study, patients eligible for conventional oral antiviral therapy (ETV, TDF and TAF) after radical surgery for HBV-HCC will be screened, and the subjects who fully meet the inclusion and exclusion criteria will be included in the study after signing the informed consent letter according to the different treatment regiments received by the patients. Baseline information will be collected and relevant test and examination data will be collected at fixed time points after the initiation of treatment. Enrolled patients will be divided into three groups according to treatment regiments: GROUP A, group B and group C. Each group is expected to include 120 subjects, and A total of 360 subjects will be collected Group A: patients in the nucleoside analogues alone group who planned or were receiving entecavir (ETV) tenofovir fumarate (TDF) propofol tenofovir fumarate (TAF) and did not add or switch to peg interferin A-2B program Group B: peG-interferon continuous administration group, subjects were given oral antiviral drugs from day 2 after surgery, and peg-interferon α-2b was combined with peg-interferon α -2B from week 4 to 8 after surgery, until peg-interferon was stopped and antiviral drugs were continued after 96 weeks Group C: polyethylene glycol interferon pulse treatment group, the subjects since 2 days after oral antiviral drugs, at the same time of 4 to 8 week after any point in time with polyethylene glycol interferon alpha 2 b, 8 weeks after stopping each combination (keep continuous oral NA) during 4 weeks, periodic, until weeks after stop using polyethylene glycol (peg) 96 interferon, continue to oral antiviral drugs Follow the instructions for oral antiviral drug administration Patients returned to the study center at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and every 12 weeks thereafter, with a 7-day treatment window and a 15-day follow-up window, until 5 years or study termination Regardless of the reason for discontinuing the study drug therapy, the investigator should try to persuade the patient to continue to complete the 5-year survival follow-up and collect the following information: patient survival status and subsequent treatment options (including targeted therapy, chemotherapy, radiotherapy, surgery and immunotherapy) The primary outcome measures were recurrence free survival (RFS), and the secondary outcome measures were the decrease of HBsAg relative to baseline and the dynamic change of cccDNA clearance rate (OS), which could be used to comprehensively compare the efficacy of combined treatment with peginterferon α-2b after radical surgery

Details
Condition Hepatocellular Carcinoma
Clinical Study IdentifierNCT05466565
SponsorXiangya Hospital of Central South University
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. 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

\. 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note