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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT03356795
Eligibility Criteria:
Inclusion Criteria:
1. Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.
2. Age: ≥ 18 years and ≤ 70 years.
3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
4. Side Effects of Chemotherapy have subsided.
5. GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.
6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
7. Expected survival ≥ 12 weeks.
8. Initial hematopoietic reconstitution with
* neutrophils (ANC) ≥ 1×10\^6/L;
* platelet (PLT) ≥ 1×10\^8/L.
9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
* serum creatinine ≤ 2×ULN;
* serum bilirubin ≤ 3×ULN;
* AST/ALT ≤ 2.5×ULN.
10. Oxygen saturation ≥ 90%.
11. Written, informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
1. Airway obstruction caused by tumor.
2. History of epilepsy or other central nervous system diseases.
3. Patients who require systemic corticosteroid or other immunosuppressive therapy.
4. History of prolonged or serious heart disease during QT.
5. history of serious cyclophosphamide toxicity.
6. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
7. Inadequate liver and renal function with
* serum creatinine \> 1.5 mg/dl;
* serum (total) bilirubin \> 2.0 mg/dl;
* AST \& ALT \> 3 x ULN.
8. Pregnant or lactating females.
9. Serious active infection during screening.
10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03356795
Study Brief:
Protocol Section:
NCT03356795