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

Trial Title: Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer

NCT ID: NCT06387368

Condition: Pancreatic Cancer Non-resectable

Conditions: Official terms:
Pancreatic Neoplasms
Capecitabine

Conditions: Keywords:
Huaier Granules
Capecitabine
Unresectable Pancreatic Cancer
Efficacy and Safety

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Huaier Granule
Description: 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.
Arm group label: Huaier treatment group

Other name: Z20000109#NMPA Approval Number#

Intervention type: Drug
Intervention name: Capecitabine
Description: Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d), day 1-14, once every 3 weeks.
Arm group label: Control group

Other name: Standard chemotherapy

Summary: 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.

Detailed description: 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 "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: May 2024

Completion date: August 2028

Lead sponsor:
Agency: Health Science Center of Xi'an Jiaotong University
Agency class: Other

Collaborator:
Agency: LinkDoc Technology (Beijing) Co. Ltd.
Agency class: Industry

Collaborator:
Agency: Huazhong University of Science and Technology
Agency class: Other

Source: Health Science Center of Xi'an Jiaotong University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06387368