Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT06387368
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06387368
Study Brief:
Protocol Section:
NCT06387368