Clinical Study Of Huaier Granule In The Treatment Of Unresectable Pancreatic Cancer

Study Overview

Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer

This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.

This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses ⋊pecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.

Pancreatic Cancer Non-resectable

DRUG: Huaier Granule
DRUG: Capecitabine

HE-202303

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 2024-04-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-23
First Submitted that Met QC Criteria 2024-04-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-29
First Posted (ACTUAL) 2024-04-29	Results First Posted N/A	Last Verified 2024-04

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:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Huaier treatment group The subjects received a combination of Huaier granules and capecitabine regimen.The subject takes Huaier granules orally, 10g once, three times a day; take capecitabine 1250mg/m^2 orally , twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.	DRUG: Huaier Granule Huaier Granules: Oral administration, 10g once, 3 times a day. Capecitabine: oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.
ACTIVE_COMPARATOR: Control group The subjects received the capecitabine monotherapy regimen. The subjects take capecitabine orally, 1250mg/m^2, twice a day (2500mg/m^2/d), day for 1-14 days, once every 3 weeks.	DRUG: Capecitabine Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Huaier treatment group

The subjects received a combination of Huaier granules and capecitabine regimen.The subject takes Huaier granules orally, 10g once, three times a day; take capecitabine 1250mg/m^2 orally , twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.

DRUG: Huaier Granule

Huaier Granules: Oral administration, 10g once, 3 times a day. Capecitabine: oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.

ACTIVE_COMPARATOR: Control group

The subjects received the capecitabine monotherapy regimen. The subjects take capecitabine orally, 1250mg/m^2, twice a day (2500mg/m^2/d), day for 1-14 days, once every 3 weeks.

DRUG: Capecitabine

Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.

Primary Outcome Measures	Measure Description	Time Frame
Overall survival	It is defined as the time from the day of patient randomization to death due to any reason.	Start of treatment until 2-year follow-up

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate	It is defined as the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, generally understood as the sum of CR and PR(CR ,complete remission ,all target lesions disappear, maintained for 4 weeks; PR ,partial remission ,it is defined as a reduction of at least 30% in the sum of the longest diameters of the target lesion compared to baseline, maintained for 4 weeks).	Start of treatment until 2-year follow-up
Progression free survival	It is defined as the period between the start of treatment and the observation of disease progression or death due to any reason for patients with pancreatic cancer in this study.	Start of treatment until 2-year follow-up
Conversion surgery rate	It is defined as the proportion of patients diagnosed as locally advanced pancreatic cancer before surgery (stage III) who can accept radical surgery after clinical evaluation; The proportion of patients with oligometastatic lesions (belonging to stage IV) who have no new lesions and significant regression of the metastatic lesions after treatment, and whose primary lesions can be removed (regardless of whether they can be removed before treatment) are clinically assessed as eligible for radical surgery.	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 ≥ 18 years old, regardless of gender.
The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).
Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.
The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.
ECOG score 0-3 points.
The patients voluntarily participate in and cooperates with all aspects of the research, including but not limited to cooperating with treatment and follow-up, cooperating with the researcher in data collection, not actively taking other treatments, and signing a written informed consent form.

Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).
Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.
After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.
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).
Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.

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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