PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.

NCT03755440 | Completed Phase 2

• 1 other identifier: EBVaGC-SYSUCC
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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(+) tumors exhibit high response to PD-1 antibody. In this phase II study, we will investigate the efficacy and safety of PD-1 antibody in EBV positive metastatic GC patients.

Conditions

Gastric Cancer Stage IV; EBV

Keywords

EBV; Gatric cancer; Check point inhibitor

Outcome Measures

Primary Outcomes (1)

• Response rate

  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 Outcomes (3)

• Progression-Free Survival (PFS)

  up to approximately 1 year

• Overall Survival (OS)

  up to approximately 2 year

• Disease Control Rate (DCR)

  From first patient first visit to 6 month after last patient first visit

Study Arms (1)

PD-1 antibody

EXPERIMENTAL

SHR-1210, 200mg, ivdrip, d1, every two weeks.

Drug: PD-1 antibody (SHR-1210)

Interventions

PD-1 antibody (SHR-1210) DRUG

PD-1 antibody (SHR-1210), 200mg, ivdrip, every 2 weeks.

PD-1 antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;
• \. 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Sun YT, Guan WL, Zhao Q, Wang DS, Lu SX, He CY, Chen SZ, Wang FH, Li YH, Zhou ZW, Xu RH, Qiu MZ. PD-1 antibody camrelizumab for Epstein-Barr virus-positive metastatic gastric cancer: a single-arm, open-label, phase 2 trial. Am J Cancer Res. 2021 Oct 15;11(10):5006-5015. eCollection 2021.

  PMID: 34765307 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Rui-Hua Xu, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: PD-1 antibody, SHR-1210

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 28, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

CN (1)