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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT05138159
Eligibility Criteria:
Inclusion Criteria:
* Informed consent and willing to complete the study according to the protocol.
* Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender
* ECOG performance scale 0-1;
* Diagnosed as pancreatic adenocarcinoma by histology and cytology;
* Treatment of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen(The disease progresses during the course of treatment or within 6 months after the end of treatment, with clear imaging evidence; this does not include patients with intolerable toxicity)；
* Baseline blood routine and biochemical indexes meet the following criteria:
1. Blood routine examination criteria must be met: (no blood transfusion within 14 days)
1. HB≥90g/L；
2. ANC≥1.5×109/L；
3. PLT≥100×109/L.
2. Biochemical tests are subject to the following criteria:
1. BIL \<1.25xULN ；
2. ALT and AST\<2.5ULN；
3. Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance\>60ml/min ( Cockcroft-Gault formula).
4. Albumin≥28g/L.
3. Blood coagulation indexes are subject to the following criteria:
1. Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;
2. Activated partial thromboplastin time（APTT）≤1.5 × ULN.
* According to the standard of RECIST 1.1, there is at least one imaging measurable lesion;
* Life expectancy ≥ 3 months;
* Patients and their families were willing to cooperate with follow-up.
Exclusion Criteria:
* Diagnosis of malignant diseases other than pancreatic cancer within 5 years prior to first administration (excluding cured skin basal cell carcinoma, squamous carcinoma of the skin, and/or resected carcinoma in situ);
* Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
* Patients with brain metastases or pial metastases;
* Patients with a clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
* Comorbidities (e.g., severe or uncontrolled hypertension, severe diabetes, and/or thyroid disease) that, in the investigator's judgment, seriously endanger patients' safety or prevent them from completing the study;
* The patient was currently participating in an interventional clinical study or had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
* The patient had a history of organ transplantation;
* Concurrent administration of drugs that may prolong QTc and/or induce Tdp;
* Patients also take drugs that affect drug metabolism;
* HIV infection or acute or chronic viral hepatitis (hbSAG positive, HBV-DNA load ≥500IU/ml and/or HCV antibody positive);
* Excluded patients with serious cardiovascular disease, including grade ≥II cardiac dysfunction (NYHA criteria);
* Patients with severe gastrointestinal dysfunction (bleeding, infection, obstruction, or diarrhea greater than grade 1) were excluded;
* Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy were excluded;
* Patients with a severe arterial thromboembolism event within 6 months were excluded;
* Excluding women who are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05138159
Study Brief:
Protocol Section:
NCT05138159