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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT04093466
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed recurrent or metastatic solid tumors;
* At least one measurable lesion (spiral CT scan long diameter ≥10 mm or enlarged lymph node short diameter ≥15 mm by RECIST 1.1);
* Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;
* ECOG PS ≤1;
* Expected overall survival≥12 weeks;
Exclusion Criteria:
* Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
* Other kinds of malignancies \[excluding stage IB or lower grade cervical cancer，noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) \> 10 years ,melanoma with CR \> 10 years or other malignant tumors with CR \> 5 years\];
* Hematologic, renal, and hepatic function abnormities as defined below:
Absolute neutrophil count (ANC) \<1.5×109 /L or platelet \<100×109 /L or hemoglobin \<9 g/dL; Total bilirubin \> 1.5×the upper limit of normal range(ULN) without liver metastases; total bilirubin \> 3×ULN with liver metastases; AST, ALT, ALP \>1.5×ULN without liver metastases ; AST, ALT, ALP \>5×ULN with liver metastases; Primary hepatocellular carcinoma; Hepatic cirrhosis with Child-Pugh B or C; Serum creatinine \>1.5×ULN; History of previous nephrotic syndrome; INR or aPPT \>1.5×ULN; Presence of hemorrhage (hemoptysis) , thrombosis，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs (Aspirin ≤100 mg/d for prophylaxis are allowed); •Any of the following gastrointestinal disease: Unable to swallow oral drugs; Need intravenous nutrition; History of a gastric resection; History of treatment for active peptic ulcer disease within 6 months; Clinically significant gastrointestinal bleeding within 3 months; Persistent grade 2 or higher chronic diarrhea despite optimal medical management;
•Any of the following cardiovascular and cerebrovascular disease: Myocardial infarction , severe cardiac arrhythmias, unstable angina, coronary artery disease, congestive heart failure, cerebrovascular accident or TIA within 12 months ; Deep vein thrombosis or pulmonary embolism within 6 months; QTcF \>470 msec; Uncontrolled hypertension despite optimal medical management;
* Presence of unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 grade 0 or 1 with the exception of alopecia;
* Involved in other clinical trials within 30 days of enrollment;
* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days of enrollment;
* History of organ allograft ;
* Need glucocorticoids or other immunosuppressive agents for immunosuppression (excluding local or inhaled glucocorticoids);
* Uncontrolled ongoing or active infection;
* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
* Pregnant or lactating women or those who do not take contraceptives, including men;
* Suffering from mental and neurological diseases;
* Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
* Inability to comply with protocol required procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04093466
Study Brief:
Protocol Section:
NCT04093466