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IPD meta-analysis of biweekly irinotecan plus cisplatin and irinotecan alone as second-line treatment for advanced gastric cancer: TCOG GI-0801BIRIP and ECRIN TRICS RCTs

IPD meta-analysis of biweekly irinotecan plus cisplatin and irinotecan alone as second-line treatment for advanced gastric cancer: TCOG GI-0801BIRIP and ECRIN TRICS RCTs - Meta-analysis of TCOG GI-0801BIRIP and ECRIN TRICS RCTs as second-line treatment for advanced gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000025367
Enrollment
298
Registered
2017-01-05
Start date
2017-01-10
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

Advanced gastric cancer

Interventions

None listed

Sponsors

Epidemiological and Clinical research Information Network (ECRIN)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.With pathologically proven gastric cancer 2. S-1 failure for Patients with Advanced and Recurrent Gastric Cancer 3. ECOG performance status<=2 4. Age 20 years old or more 5. Life expectancy estimated>=12 weeks 6. Sufficient organ functions

Exclusion criteria

Exclusion criteria: (1) Blood transfusion, blood products, or hematopoietic factor products, such as G-CSF, within 14 days before enrollment of this study. (2) Present and/or drug hypersensitivity or severe drug allergy. (3) Active double cancer. (4) With uncontrolled pleural effusion or ascites. (5) With pericardial effusion. (6) With infectious disease which needs treatment. (7) With symptomatic brain metastasis. (8) With marked ECG abnormalities. (9) With serve heart diseases, such as congestive heart failure, symptomatic coronary artery disease, inadequately controlled arrhythmia, myocardial infarction during the previous 12 months, etc. (10) With severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.). (11) With fresh gastrointestinal hemorrhage. (12) Watery stool (diarrhea). (13) Intestinal paralysis or ileus. (14) With a history of central nervous system disorder. (15) With senile dementia. (16) With psycologic disorder which disturbs recruiting to the study (17)Uncontrolled diabetes mellitus. (18) Receiving atazanavir sulfate. (19) Pregnant and/or nursing women. (20) Inappropriate recruit to the study judged by an investigator in charge.

Design outcomes

Primary

MeasureTime frame
Overall survival: OS

Secondary

MeasureTime frame
PFS: Progression-free survival TTF: time to treatment failure RR: Response rate DCR: Disease control rate Adverse events

Countries

Japan

Contacts

Public ContactKazuhiro Nishikawa

Osaka National Hospital Department of Surgery

kazuno13@hotmail.co.jp06-6942-1331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026