Status:
COMPLETED
PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.
Lead Sponsor:
Sun Yat-sen University
Conditions:
Gastric Cancer Stage IV
EBV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
EBV positive tumor accounts for 8-9% of all gastric cancer (GC) patients. PD-1 antibody has been proved as third line therapy for PD-L1 positive gastric cancer. Previous studies showed that EBV(+) tum...
Detailed Description
EBV positive metastatic GC patients who failed to standard chemotherapy will receive therapy of single agent, PD-1 antibody, SHR-1210, 200mg, every 2 weeks. The primary endpoint is response rate. Seco...
Eligibility Criteria
Inclusion
- Histologically confirmed Recurrent/Metastatic gastric adenocarcinoma;
- EBER positive;
- Failed from first-line platinum and fluorouracil based chemotherapy and second-line chemotherapy; or could not tolerate systematic chemotherapy
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
- Can provide either a newly obtained or archival tumor tissue sample;
- Adequate laboratory parameters during the screening period as evidenced by the following:
- Absolute neutrophil count ≥ 1.5 × 10\^9/L ; Platelets ≥ 90 × 10\^9/L; Hemoglobin ≥ 9.0 g/dL; Serum albumin ≥ 2.8g/dL; Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 1.5×ULN Creatinine clearance≥50 mL/min;
- Female of child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 60 days after the last dose of SHR-1210. Male subjects must be willing to use adequate contraception for the course of the study through 120 days after the last dose of SHR-1210;
- Subjects must be willing to participate in the research and sign an informed consent form (ICF);
Exclusion
- Subjects with any active autoimmune disease or history of autoimmune disease;
- Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema, requiring steroids intervention, or brain metastasis progression);
- Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical cancers;
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy;
- Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy within 4 weeks prior to first dosing or not recovered to ≤CTCAE 1 from adverse events (except for hair loss or neurotoxic sequelae from prior platinum therapy) due to a previously administered agent. 7. Palliative irradiation finished within 2 weeks;
- 8\. Active infection or an unexplained fever \> 38.5°C before two weeks of first dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 9. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C; 10. Currently participating or has participated in a study within 4 weeks of the first dose of study medication; 11. Pregnancy or breast feeding; 12. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; 13. Subjects are known to have a history of psychiatric substance abuse, alcoholism, or drug addiction; 14. According to the investigator, other conditions that may lead to stop the research.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03755440
Start Date
December 1 2018
End Date
December 31 2020
Last Update
September 21 2022
Active Locations (1)
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1
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060