Analysis of intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer.

Analysis of intratumoral immune response early on Nivolumab treatment in unresectable advanced or recurrent gastric cancer. - Intratumoral immune response early on Nivolumab treatment in gastric cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029622

Enrollment

Registered

2017-10-19

Start date

2017-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable advanced or recurrent gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically diagnosed gastric or esophagogastric junction adenocarcinoma. 2.Unresectable advanced or recurrent tumor. 3.Age over 20 years old. 4.ECOG Performance status of 0-2. 5.With lesions being able to be biopsied (measurable lesions not required). 6.With valuable lesion according to RECIST ver 1.1. 7.More than 42 days after failure of standard therapy. 8.More than 14 days after last infusion of chemotherapy. 9.Adequate organ and marrow functions as defined below within 14 days prior to registration: (i)Absolute neutrophil =>1,000/mm3. (ii)Hemoglobin =>9.0g/dL. (iii)Platelet =>50,000/mm3. (iv)Total bililubin =<2.0xupper limits of normal (ULN) . (v)AST =<3.0xULN (in the case or liver metastases, physician's choice is allowed) . (vi)ALT =<3.0xULN (in the case or liver metastases, physician's choice is allowed) . (vii)Creatinine =<1.5mg/dL or eGFR =>45ml/min/1.73m2. 10.Written Informed Consent.

Exclusion criteria

Exclusion criteria: 1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2.Active infection requiring systemic therapy. 3.Active autoimmune diseases or with a history of chronic or repetitive autoimmune diseases. 4.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis. 5.Active diverticulitis or inflammatory bowel disease. 6.Poorly controlled diabetes mellitus or thyroid diseases. 7.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months. 8.Severe psychological illness. 9.Pregnant or lactating women or women of childbearing potential. 10.Within 4 weeks after live vaccination or 2 weeks after inactiviated vaccination. 11.Judged to be unfit to participate in this study by investigater.

Design outcomes

Primary

Measure	Time frame
Durable clinical benefit rate, DCBR (DCR more than 4 months)	—

Secondary

Measure	Time frame
Immunological responses Response rate, RR Disease control rate, DCR Progression free survival, PFS Overall survival, OS Adverse events, AE Quality of life, QOL	—

Countries

Japan

Contacts

Public ContactHiroharu Yamashita

The University of Tokyo Department of Gastrointestinal Surgery

hyamashi-tky@umin.net03-3815-5411

Outcome results