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RECRUITING
NCT06368063
PHASE4

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

Sponsor: Xi'an Jiaotong University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

642

Start Date

2024-05-06

Completion Date

2028-03

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DRUG

Huaier 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.

DRUG

chemotherapy 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.

Locations (1)

Zheng Wang

Xi'an, Shannxi, China