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

Health Science Center of Xi'an Jiaotong University

Status and phase: Enrolling; Phase 4

Conditions: Pancreatic Cancer Resectable

Treatments: Drug: Huaier granule; Drug: chemotherapy drugs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06368063

HE-202301

Details and patient eligibility

About

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

Full description

The study is a multicenter, prospective clinical study, expected to include subjects who visited the selected research center from April 2024 to March 2026, underwent radical tumor resection surgery, and were pathologically diagnosed with pancreatic adenocarcinoma. The subjects are divided into two groups. One group is the standard chemotherapy group, with a planned inclusion of no less than 428 subjects. The chemotherapy will be treated using the Class 1A chemotherapy regimen recommended by the 2022 version of the CSCO guidelines; One group is the Huaier treatment group, with a planned inclusion of no less than 214 subjects. All subjects voluntarily give up the postoperative adjuvant treatment recommended by the guidelines and only choose Huaier granules for postoperative adjuvant treatment. A total of no less than 642 subjects are planned to be included.

Enrollment: 642 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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642 participants in 2 patient groups

Huaier treatment group

Experimental group

Description:

The subjects take Huaier granules orally and start taking them within 15-30 days after surgery until the end of the study, intolerable toxicity occurs, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.

Treatment:

Drug: Huaier granule

Standard chemotherapy group

Active Comparator group

Description:

Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment) * Gemcitabine combine with capecitabine * mFOLFIRINOX solution * Gemcitabine monotherapy * Tegafur，gimeracil and oteracil potassium capsules monotherapy

Treatment:

Drug: chemotherapy drugs