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Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC

ConditionHepatocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHua Li

About this trial

This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years;

ECOG Performance Status (PS) of 0 or 1;

Histologically or cytologically diagnosed as HCC

Fully recovered from surgical resection or ablation prior to enrollment;

Disqualifiers

Known cases of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;

HCC recurrence prior to study enrollment;

Co-infection with HBV and delta hepatitis virus;

Clinically significant ascites (Note: ascites detectable only through imaging studies are permitted to participate in the study);

Trial design

Design model

Single group

Treatments tested in this trial

  • Icariin Soft Capsules+TACE

    Drug

    TACE: perform preoperative infusion chemotherapy, then selectively inject 2 to 5 mL of iodized oil and embolize. Icariin Soft Capsules：take 6 tablets each time, orally, twice a day.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Icariin Soft Capsules + TACEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence Free Survival Rate

The proportion of patients who did not experience recurrence or death

Time frame
12 months

Secondary outcomes

1

Disease Free Survival

DFS defined as the time from date of treatment until the date of recurrence or death due to any cause

Time frame
24 months
2

Overall survival (OS)

OS defined as the time from date of treatment until the date of death due to any cause

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hua Li

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: