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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT02858232
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically-confirmed, advanced (unresectable) solid tumors（Lung cancer, colon cancer, prostate cancer, soft tissue sarcoma, other rare tumor） who have progressed on standard therapy.
2. With written informed consent signed voluntarily by patients themselves.
3. The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
4. ECOG≤2.
5. At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
6. Life expectancy ≥6 months.
7. With normal cardiopulmonary function.
8. Patients have adequate organ function as defined by the following criteria:
Hemoglobin (HGB) ≥85g/L Absolute neutrophil count (ANC) ≥1.0×10\^9/L White blood cell (WBC) ≥3.0×10\^9/L Platelet count ≥80×10\^9/L Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis Alkaline phosphatase (ALP)≤2.5 UNL Total bilirubin (TBil) of ≤1.5 UNL Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL Albumin (ALB) ≥30g/L
Exclusion Criteria:
1. Pregnant or expecting to pregnant
2. Participated in other clinical trials before screening except of observational study.
3. Refused to provide blood samples.
4. Known allergic history of sodium citrate drugs.
5. Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
6. Known active brain metastases
7. The use of immunosuppressive drugs with current or 14 days before enrollment.
8. Active primary immune deficiency.
9. known history of tuberculosis.
10. Active infection, including hepatitis B, hepatitis C virus, or human immunodeficiency virus.
11. Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
12. Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
13. Clinical signs of heart disease.
14. Treatment with any anti-tumors agent within 28days of first administration of study treatment.
15. The research on the influence of non legal persons, medical or ethical reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02858232
Study Brief:
Protocol Section:
NCT02858232