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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03781050
Eligibility Criteria:
Inclusion Criteria:
* Patients are diagnosed with PJS.
* Patients have gastrointestinal polyps related syndromes, including abdominal pain, abdominal distension, gastrointestinal bleeding, etc, with imageological examination suggesting intestinal obstruction or intussusception; or whose symptoms recur after previous digestive endoscopic treatment and surgery; or who are inappropriate or unwilling to accept the above treatment again and wish to receive pharmacotherapy.
* Conventional treatment didn't work well in patients combined with PJS-related tumors.
* Physical condition (ECGO): 0\~3
* Organ function is good and biochemical indices meet the following conditions:
* AST≤2.5×upper limit of normal value (ULN),
* ALT≤2.5×upper limit of normal value (ULN),
* Serum total bilirubin (TSB)≤1.5×upper limit of normal value (ULN),
* Creatinine≤1.5×upper limit of normal value (ULN).
* No other medications have been received for intestinal polyps within 3 months prior to the clinical trial.
* Patients participate in the trial voluntarily and have signed the informed consent by the participant or his/her legal guardian.
Exclusion Criteria:
* Patients underwent a surgery within 2 weeks.
* Patients may need emergency surgery in the near future.
* Patients are allergic to any ingredient of rapamycin.
* Patients suffer from a disease requiring immediate blood transfusion.
* Patients suffer from any disease or condition that may impact implementation of the study or interpretation of the results. This type of diseases includes:
* Known severe blood coagulation disorders
* Known anemia that is not caused by intestinal polyps
* Known hemoglobinopathy
* Other gastrointestinal infectious diseases
* Serious heart, liver, kidney and other concomitant diseases that may endanger lives
* Patients are in pregnancy and lactation.
* Alcohol or drug (such as aperient) abuse
* Patients took part in another clinical trial that may influence this study.
* The researchers believe that there are other unfavorable reasons for the patient to become a subject.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03781050
Study Brief:
Protocol Section:
NCT03781050