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

NCT ID: NCT06368063

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 642 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2028-03-31

Brief 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

Detailed 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.

Conditions

Pancreatic Cancer Resectable

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Huaier treatment group

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.

Group Type: EXPERIMENTAL

Huaier granule

Intervention Type: DRUG

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.

Standard chemotherapy group

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

Group Type: ACTIVE_COMPARATOR

chemotherapy drugs

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Z20000109#NMPA Approval Number#; Standard chemotherapy

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Zheng Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zheng Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Zheng Wang

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Wang, PhD

Role: CONTACT

zheng.wang11@mail.xjtu.edu.cn

+8615902993665

Liang Han, PhD

Role: CONTACT

hanliangxjtu@163.com

+8613379181359

Facility Contacts

Zheng Wang, PhD

Role: primary

zheng.wang11@mail.xjtu.edu.cn

+8615902993665

Liang Han, PhD

Role: backup

hanliangxjtu@163.com

+8613379181359

Other Identifiers

HE-202301

Identifier Type: -

Identifier Source: org_study_id