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

NCT06368063 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2024-05-08

No results posted yet for this study

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

Conditions

  • Pancreatic Cancer Resectable

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.

Sponsors & Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

    collaborator INDUSTRY

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Zheng Wang, PhD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2026-03-31
Completion
2028-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368063 on ClinicalTrials.gov