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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT03662035
Eligibility Criteria:
Inclusion criteria:
* 18-70 years old;
* ECOG score: 0-2;
* Have confirmed metastatic or locally advanced unresectable pancreatic cancer;
* At least one measurable lesion according to the RECIST1.1 standard;
* First-line chemotherapy drugs do not include S-1 or fluorouracil drugs;
* Main organ functions meet the following standards:
* Baseline blood routine (the inspection standard should meet the requirements of no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulant correction) :
* Hemoglobin\>80g/L
* The absolute neutrophil count (ANC) 1.5 x 109 / L;
* Blood platelet (PLT)\> 90 x 109 / L;
* Baseline biochemical test shall meet the following standards:
* T BIL \< 1.5\*ULN.
* A LT and AST\<2.5\*ULN, and in patients with liver metastasis \< 5\*ULN;
* Cr≤1.5\*ULN.
* Albumin is greater than or equal to 30g/L;
* Women of child-bearing age must already have access to reliable contraception. Pregnancy tests (serum or urine) were performed within 7 days prior to enrollment and the results were negative, and a reliable method of contraception was preferred 8 weeks after the trial period and the last drug administration;
* Subjects will voluntarily join the study and sign the informed consent.
Exclusion criteria:
* Clearly allergic to apatinib, S-1 or their excipients;
* There are various factors affecting oral drugs (including dysphagia, chronic diarrhea, intestinal obstruction, etc.);
* Serious heart diseases in the last six months, including :
* angina;
* myocardial infarction;
* heart failure;
* interphase of QTc \>450ms;
* any other heart diseases that were judged as unsuitable for the study;
* Combined with uncontrollable hypertension after drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg);
* Complicated with other serious medical diseases, including cerebrovascular disease, uncontrolled infection, active peptic ulcer, intestinal obstruction, etc.;
* Metastasis of tumor central nervous system;
* Women during pregnancy and lactation;
* The patient has been diagnosed with other tumors in the past five years, except for the following situations: B. Cured basal cell carcinoma of the skin and cured orthotopic carcinoma of the cervix;
* The time from the last chemotherapy is shorter than 4 weeks or 5 half-life (the time taken is older), and the time from the last radiotherapy is shorter than 4 weeks;
* Use the experimental drug within 28 days before enrollment;
* Patients with grade 2 or above toxicity caused by the use of anti-tumor drugs before enrollment;
* Have mental disorders or a history of substance abuse;
* Other circumstances that the investigator deems inappropriate to participate in the study;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03662035
Study Brief:
Protocol Section:
NCT03662035