PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.
Phase II Study of PD-1 Antibody SHR-1210 in EBV Positive Metastatic Gastric Cancer Patients.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Cancer center of Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: PD-1 antibody
SHR-1210, 200mg, ivdrip, d1, every two weeks.
|
PD-1 antibody (SHR-1210), 200mg, ivdrip, every 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response rate
Time Frame: From first patient first visit to 6 month after last patient first visit ] Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
|
The percentage of patients whose cancer shrinks or disappears after treatment
|
From first patient first visit to 6 month after last patient first visit ] Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (PFS)
Time Frame: up to approximately 1 year
|
PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
|
up to approximately 1 year
|
|
Disease Control Rate (DCR)
Time Frame: From first patient first visit to 6 month after last patient first visit
|
Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
|
From first patient first visit to 6 month after last patient first visit
|
|
Overall Survival (OS)
Time Frame: up to approximately 2 year
|
The time from registration to death due to any cause, or censored at date last known alive.
|
up to approximately 2 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Rui-hua Xu, MD, PhD, Sun Yat-sen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- EBVaGC-SYSUCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Cancer Stage IV
-
NCT03395847CompletedClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
-
NCT00062374CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric Cancer
-
NCT04248452Active, not recruitingClinical Stage IV Gastric Cancer AJCC v8 | Metastatic Gastric Adenocarcinoma | Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVB Gastric Cancer AJCC v8 | Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage IV Gastric Cancer AJCC v8 | Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
-
NCT06342427CompletedGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion
-
NCT04220827Active, not recruitingPeritoneal Carcinomatosis | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 | Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Clinical Stage IVB Gastric Cancer AJCC v8
-
NCT02333188CompletedPancreatic Adenocarcinoma | Gastric Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Malignant Gastrointestinal Neoplasm | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Gallbladder Carcinoma | Stage IV Gallbladder Cancer | Stage IV Gastric Cancer | Stage IIIA Gallbladder Cancer
-
NCT03161522RecruitingGastric Adenocarcinoma | Oligometastasis | Stage IV Esophageal Cancer AJCC v7 | Stage IV Gastric Cancer AJCC v7 | Stage IV Esophageal Adenocarcinoma AJCC v7
-
NCT01939275CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer | Stage IIA Gastric Cancer
-
NCT01191684CompletedRecurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IV Colon Cancer | Stage IV Rectal Cancer | Stage IV Gastric Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Recurrent Gastric Cancer | Stage III Colon Cancer
-
NCT00006389CompletedStage IV Gastric Cancer | Stage III Gastric Cancer
Clinical Trials on PD-1 antibody (SHR-1210)
-
NCT03222440CompletedEsophageal Cancer
-
NCT04790539Not yet recruitingExtensive Stage Small Cell Lung Cancer
-
NCT03914352Unknown
-
NCT03631615Unknown
-
NCT03945604CompletedTriple Negative Breast Cancer
-
NCT03200691UnknownEsophageal Neoplasms | Esophageal Diseases
-
NCT04889768Not yet recruitingGastric Cancer, HIPEC, Anti-PD-1 Antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery
-
NCT04014101UnknownHepatocellular Carcinoma
-
NCT03722875UnknownHepatocellular Carcinoma
-
NCT03346642UnknownPrimary Mediastinal Large B-cell Lymphoma