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

Inclusion Criteria6

Age range from 18 to 80 years old, regardless of gender;
Pancreatic cancer was diagnosed by histopathology after radical surgery within 12 weeks before enrollment;
Did not receive neoadjuvant therapy before surgery and did not receive any adjuvant therapy after surgery;
ECOG score 0-3 points;
Those who choose to use standard chemotherapy independently based on their own situation, or choose Huaier granules for subsequent treatment, voluntarily participate in and cooperate with various research work, including but not limited to cooperating with treatment and follow-up, cooperating with researchers for data collection, and not actively taking other treatments.
The subjects voluntarily signed a written informed consent form before participating in this study.

Exclusion Criteria9

Known to be allergic to the components of Huaier granules or to avoid or use Huai er granules with caution (Huaier group);
Difficulties in taking oral medication due to active gastrointestinal bleeding, perforation, gastric paralysis, etc;
Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.
History of merging with other malignant tumors;
Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment;
Concomitant severe infection;
Child Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate\<90ml/min);
Pregnant or lactating women or those planning to conceive;
The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).

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.