Phase II study of ramucirumab and irinotecan combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer

Phase 2

• Conditions: Gastric Cancer

• Registration Number: JPRN-UMIN000030372
• Lead Sponsor: Hokkaido Gastrointestinal Cancer Study Group (HGCSG)

Brief Summary

Progression-free survival rate at 6 months was 26.5% (95%CI, 13.2-41.8%, P = 0.1353). This study did not meet its primary endpoint.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-13
• Study Completion: 2020-09-30
• Results First Posted: 2022-05-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1. Major surgery within 28 days before registration. 2. The patient has a history of DVT, PE, or any other significant thromboembolism during the 3 months prior. 3. Administration of anticoagulant therapy such as warfarin and LMWH. 4. The patient is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. 5. Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression. 6. Diagnosis of arterial hypertension that cannot be controlled with standard medical management. 7. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy. 8. Primary cancers diagnosed within the previous five years. 9. The patient has symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia. 10. The patient has experienced any arterial thrombotic event within 6 months prior. 11. Serious complications or comorbidities. 12. The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy. 13. History of gastrointestinal perforation and/or fistulae within 6 months prior to registration. 14. Pericardial or pleural effusion or ascites requiring treatment including drainage. 15. Pregnancy, breast-feeding, or plans of pregnancy. 16. Local or systemic active infection requiring treatment; however, HBs-Ag positive patients controlled by nucleic acid analogs and those confirmed as HBV DNA can be enrolled. 17. Current or recent treatment with another investigational drug or participation in another interventional clinical trial. 18. Have known allergy or hypersensitivity to any components of study treatment. 19. The patient has: cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. 20. Participation in the clinical trial is determined as unsuitable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified