RecruitingPhase 4NCT06368063

The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer

Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer

Sponsor

Xi'an Jiaotong University

Enrollment

642 participants

Start Date

May 6, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Resectable

Summary

The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether Huaier Granule, a traditional Chinese herbal medicine, can help prevent recurrence of pancreatic cancer after surgery when used alongside or instead of standard chemotherapy. **You may be eligible if...** - You are between 18 and 80 years old - You had surgery to remove pancreatic cancer and the pathology confirmed the diagnosis within the past 12 weeks - You did not receive chemotherapy or other cancer treatment before or after your surgery (prior to enrolling) - Your performance status is adequate (ECOG 0–3) **You may NOT be eligible if...** - You received neoadjuvant (pre-surgery) or adjuvant (post-surgery) therapy before enrollment - You have significant other health conditions that would interfere with treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuaier granule

Huaier Granules: Oral administration, 10g once, 3 times a day, starting from 15-30 days after surgery until the end of the study, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.

DRUGchemotherapy drugs

Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment) · Gemcitabine combine with capecitabine Gemcitabine 1000mg/m\^2 intravenous infusion for more than 30 minutes, day 1, 8, 15,repeat every 4 weeks for a total of 6 cycles. · mFOLFIRINOX solution Oxaliplatin 85mg/m\^2 intravenous infusion for 2 hours, day 1 Ilitacan 150mg/m\^2 intravenous infusion for more than 30-90 minutes, day 1 Leucovorin calcium 400mg/m\^2 intravenous infusion for 2 hours, day 1 5-FU 2400mg/m\^2, continuous intravenous infusion for 46 hours, repeated every 2 weeks, administered until 24 weeks. * Gemcitabine monotherapy 1000mg/m\^2 intravenous infusion, day 1 qw x 7, rest for 1 week Afterwards, qw × 3, take a week off, and administer medication for 6 months. * Tegio capsules monotherapy Take tegio capsules orally, 80mg/d, day 1-28, repeated every 6 weeks, administered until 6 months.