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.
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.
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.
Parallel
Huaier Granule
DrugHuaier 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.
Capecitabine
DrugOral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d), day 1-14, once every 3 weeks.
Overall survival
It is defined as the time from the day of patient randomization to death due to any reason.
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).
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.
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.
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.
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Xi'an Jiaotong University
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
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