The Study Of Huaier Granule In Postoperative Adjuvant Therapy Of Resectable Pancreatic Cancer

Study Overview

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

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

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.

Pancreatic Cancer Resectable

DRUG: Huaier granule
DRUG: chemotherapy drugs

HE-202301

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-04-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-07
First Submitted that Met QC Criteria 2024-04-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-08
First Posted (ACTUAL) 2024-04-16	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 determine	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 determine
ACTIVE_COMPARATOR: 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 monot	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 f

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 determine

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 determine

ACTIVE_COMPARATOR: 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 monot

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 f

Primary Outcome Measures	Measure Description	Time Frame
Disease-free survival	It is defined as the time from the first day after radical resection of pancreatic cancer to recurrence or all-cause death of pancreatic cancer.	Start of treatment until 2-year follow-up

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival	It is defined as the time between the start date of enrollment and the recorded date of all-cause death. For subjects who were lost to follow-up before death, the last follow-up time is usually calculated as the time of death.	Start of treatment until 2-year follow-up
Progression-free survival	It is defined as the time between the start date of enrollment and the date of imaging progression or all-cause death evaluated by the investigator.	Start of treatment until 2-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)	The definitions and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.	Start of treatment until 2-year follow-up
The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)	The definitions and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.	Start of treatment until 2-year follow-up

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zheng Wang, PhD

Phone Number: +8615902993665

Email: zheng.wang11@mail.xjtu.edu.cn

Study Contact Backup

Name: Liang Han, PhD

Phone Number: +8613379181359

Email: hanliangxjtu@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

LinkDoc Technology (Beijing) Co. Ltd.
Huazhong University of Science and Technology

Investigators

PRINCIPAL_INVESTIGATOR: Zheng Wang, PhD, First Affiliated Hospital Xi'an Jiaotong University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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