Evaluating Huaier Granule as Post-Surgery Additional Treatment for Resectable Pancreatic Cancer Compared to Standard Chemotherapy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Huaier Granule as a postoperative adjuvant treatment for patients with resectable pancreatic cancer. This multicenter, prospective clinical study includes individuals who have undergone radical tumor resection and have been pathologically diagnosed with pancreatic adenocarcinoma. The study compares Huaier Granule treatment with standard chemotherapy regimens recommended by the 2022 CSCO guidelines. Participants are divided into two groups one receiving standard chemotherapy, which includes options like gemcitabine combined with capecitabine, mFOLFIRINOX, gemcitabine monotherapy, or tegafur capsules and the other receiving Huaier Granules orally, starting 15-30 days after surgery. Huaier is taken as 10g three times daily until the study ends, intolerable side effects occur, withdrawal, death, or the researcher decides there is no further benefit. During the study, participants will be monitored through regular follow-up visits for up to two years, tracking disease-free survival as the primary outcome. Researchers will also assess overall survival, progression-free survival, and the incidence and severity of adverse events and adverse drug reactions. The study aims to gather comprehensive data on treatment outcomes and safety over this period.

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