HGCSG1603

JRCT ID: jRCTs011180029

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 09/05/2018
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Ramucirumab and irinotecan combination therapy is administered.

Outcome(s)

• Primary Outcome: progression-free survival rate at six months (PFS rate at 6 months)
• Secondary Outcome: overall survival, progression-free survival, response rate, safety, and dose intensity for each drug

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Confirmed stage IV or recurrent gastric adenocarcinoma that is refractory or intolerant to initial chemotherapy.
2. Age of 20 years or older.
3. ECOG PS scale 0-1.
4. No history of treatment with irinotecan.
5. Confirmation of the progression or recurrence following initial treatment and potential presence of an evaluable lesion less than 28 days before registration using CT or MRI findings, according to RECIST version 1.1. Presence or absence of a measurable lesion is not an inclusion criterion.
6. Last day of initial chemotherapy administration is more than 14 days before registration.
7. Fulfillment of the standards related to major organ functions within 14 days before registration.
8. Patients who are negative for HER-2/neu and those with unknown HER-2/neu status are eligible. HER-2/neu-positive patients are eligible if they received treatments including trastuzumab and if the disease progress is confirmed.
9. Available written informed consent.
10. Have an estimated life expectancy of >12 weeks in the judgment of the investigator.
11. The patient, if female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 12 weeks after the treatment period.

Exclude 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.

Related Information

• Primary Sponsor: Komatsu Yoshito
• Secondary Sponsor: HOKKAIDO GASTROINTESTINAL CANCER STUDY GROUP (HGCSG)
• Secondary ID(s): UMIN000030372