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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT03644459
Eligibility Criteria:
Inclusion Criteria:
* patients with histopathologically-documented, measurable or non measurable {evaluable}, advanced solid tumors refractory
* a life expectancy of \>3 months
* ECOG performance status score of ≤ 2 at study entry
* able to provide written informed consent.
* use of effective contraceptive measures if procreative potential exists.
* an absolute neutrophil count ≥1500/mm3
* a hemoglobin level ≥ 9gm/dL
* a platelet count ≥100,000/mm3
* a total bilirubin level ≤1.5 x the ULN
* aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤2.5 x the ULN or ≤5 x the ULN if known liver metastases
* adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN.
Exclusion Criteria:
* patients with any active infection (nail bed induced fungal infections were excluded), chronic infections, and tuberculosis history.
* the females were pregnant, or lactating or showed positive urine pregnancy reaction during screening.
* patients with severe heart disease, heart failure, asthma, chronic obstructive pulmonary disease or neuropsychiatric diseases.
* uncontrolled diabetes or poor compliance with hypoglycemics;
* the presence of chronically unhealed wound or ulcers
* other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
* newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids for brain edema). Anticonvulsants are allowed.
* peritoneal carcinomatosis
* pregnancy (confirmed by serum beta human chorionic gonadotropin \[ßHCG\]) or breast-feeding (for female patients only).
* a known history or clinical evidence of a deep vein or arterial thrombosis, or pulmonary embolism
* less than six weeks from last infusion of any anti-VEGF monoclonal antibody therapy
* known history of human immunodeficiency virus infection (HIV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03644459
Study Brief:
Protocol Section:
NCT03644459