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 "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
488
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.
Oral 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.
Time frame: Start of treatment until 2-year follow-up
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Start of treatment until 2-year follow-up