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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT02857166
Eligibility Criteria:
Inclusion Criteria:
1. Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.
* at least one prior chemotherapy regimen
* age between 18 and 75 years, both gender
* has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
2. life expectancy ≥ 3 months
3. ECOG performance status of 0 or 1
4. Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy.
5. Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001.
6. Has had last administration of immunosuppressive systemic steroid therapy (more than 10 mg/d prednisone or equal dose) more than 2 weeks prior to the first dose of study therapy JS001.
7. Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS001. Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery. Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS001.
8. The lab examination results of the screening must fulfill all of the following:
* absolute neutrophil count more than or equal to 1.5×109/ L
* platelet count more than or equal to 90×109/ L
* hemoglobin more than or equal to 90 g/L
* creatinine less than or equal to132.6µmol/L or creatinine clearance \>40 mL/min
* aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 3.0 ×ULN
* total bilirubin less than or equal to 1.5×ULN( except for the patients with Gilbert syndrome, whose total bilirubin ,must less than or equal to 51.3µmol/L)
9. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study related activities.
10. Able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
1. Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.
2. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.
3. Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.
4. Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. Has interstitial lung disease OR has had a history of pneumonitis that has required oral or IV steroids.
7. Has active or suspected autoimmune disease except leukoderma,type I Diabetes, Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy, Or disease that rarely relapse without external stimulating factors.
8. Had prior treatment targeting PD-1: anti-PD-1,anti-PD-L1, anti-PD-L2, cytotoxic T-lymphocyte-associated protein (CTLA), or other antibodies that targeting T cell costimulatory pathway or checkpoint.
9. Has an active infection requiring systematic therapy.
10. Is positive for Human Immunodeficiency Virus (HIV).
11. Has active Tuberculosis.
12. Has known active Hepatitis B or C.
13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
14. Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.
15. Is pregnant or breastfeeding.
16. Cannot tolerate vein puncture and / or venous access.
17. Any other conclusive medical reasons, mental illness, and / or social reasons that determined by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02857166
Study Brief:
Protocol Section:
NCT02857166