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

NCT ID: NCT03755440

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-12-31

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.

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. Secondary endpoint is progress free survival, overall survival, safety and quality of life. Using the Simon two-stage sample size calculation, the sample size is 19. We will collect tissue and blood sample for exploratory analysis, including PD-L1 stuatus, tumor mutation burden, et al.

Conditions

Gastric Cancer Stage IV; EBV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 antibody

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

Group Type: EXPERIMENTAL

PD-1 antibody (SHR-1210)

Intervention Type: DRUG

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

Interventions

PD-1 antibody (SHR-1210)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed Recurrent/Metastatic gastric adenocarcinoma;

2. EBER positive;

3. Failed from first-line platinum and fluorouracil based chemotherapy and second-line chemotherapy; or could not tolerate systematic chemotherapy

4. ECOG performance status of 0 or 1;

5. Life expectancy ≥ 12 weeks;

6. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;

7. Can provide either a newly obtained or archival tumor tissue sample;

8. 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;

9. 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;

10. Subjects must be willing to participate in the research and sign an informed consent form (ICF);

Exclusion Criteria

1. Subjects with any active autoimmune disease or history of autoimmune disease;

2. Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema, requiring steroids intervention, or brain metastasis progression);

3. 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;

4. 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;

5. 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;

6. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Xu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui-Hua Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 34765307 (View on PubMed)

Other Identifiers

EBVaGC-SYSUCC

Identifier Type: -

Identifier Source: org_study_id