Phase II study of FTD/TPI plus RAM compared with FTD/TPI for advanced gastric cancer (WJOG15822G)

JRCT ID: jRCTs041220120

Registered date:21/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer, esophagogastric junction adenocarcinoma
• Date of first enrollment: 23/01/2023
• Target sample size: 110
• Study type: Interventional

Intervention(s)

Standard of care group (Group A) FTD / TPI monotherapy
FTD/TPI (35mg/m2) is orally administered twice daily for 5 days, followed by a 2 days rest period. After repeating this twice, the drug is withdrawn for 14 days. The above is one course and is repeated every 4 weeks until the protocol discontinuation criteria are met.

Study treatment group (Group B) FTD/TPI plus Ramucirumab (RAM)
FTD/TPI (35mg/m2) is orally administered twice daily for 5 days, followed by a 2 days rest period. After repeating this twice, the drug is withdrawn for 14 days. RAM (8 mg/kg) is administered on day 1 and day 15.
The above is one course and is repeated every 4 weeks until the protocol discontinuation criteria are met.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival, Response rate, Disease control rate, Rate of adverse events

Key inclusion & exclusion criteria

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

Include criteria

1. Age is 20 years or older.
2. Histologically diagnosed as adenocarcinoma (general type) of the gastric or esophagogastric junction.
3. HER2 test has been performed before registration (regardless of HER status).
4. Unresectable progression or recurrence comfirmed by CT scan.
5. ECOG performance status (PS) is 0 or 1.
6. Expected to survive for 3 months or more.
7. One or more measurable lesions.
8. Pretreatment (refractory or intolerant to the following drugs).
Fluoropyrimidine, Taxane or Irinotecan (Eligible even if you have used both drugs), Ramucirumab (eligible only for refractory cases)
9. Organ and bone marrow functions are maintained.
10. Written consent has been obtained.

Exclude criteria

1. Have active double cancer (simultaneous double cancer / multiple cancer and metachronous double cancer or multiple cancer with a disease-free period of 2 years or less).
2. Oral intake is difficult. Specifically, cases that require daily infusion for nutrition and water intake purposes even after registration.
3. Pre-treatment including FTD / TPI in the past.
4. Have hypersensitivity of the drugs used in this study.
5. Past history of major surgery (general anesthesia required) within 4 weeks before registration and radiation therapy covering the abdomen within 2 weeks. However, examination laparoscopy performed for diagnostic purposes is excluded.
6. Cases with severe pleural effusion (when occupying more than half of the thoracic cavity, or when frequent thoracentesis is required).
7. Have severe ascites or have a history of palliative ascites puncture (excluding test puncture for examination) within 2 weeks.
8. Cases with brain metastasis and tumor metastasis to the central nervous system
9. Adverse events (non-hematological toxicity) of poorly controlled Grade 2 or higher (CTCAE v5.0) remain at the time of registration (hair loss, dysgeusia, pigmentation, peripheral neuropathy could be registerd even if Grade 2 or higher)
10. Have a local or systemic active infection that requires treatment.
11. Despite antihypertensive drug treatment, he has uncontrolled hypertension.
12. Complicated with uncontrolled diabetes.
13. Unstable angina (angina that develops or is exacerbated by attacks within 4 weeks prior to enrollment), uncontrolled heart failure, arrhythmia requiring treatment (mild right bundle branch block, extrasystoles, etc.) Excluding arrhythmias that are not clinically problematic).
14. Have serious hemorrhagic disorders or vasculitis. Cases with significant gastrointestinal bleeding episodes (Grade 3 or higher) within 12 weeks prior to enrollment.
15. Have a history of gastrointestinal perforation or fistula within 24 weeks prior to registration.
16. Have a history of gastrointestinal obstruction or inflammatory bowel disease such as Crohn's disease. However, regarding gastrointestinal obstruction, cases in which colostomy or bypass surgery has been performed in the past and oral intake is sufficiently possible are excluded.
17. Have a history of unrecovered trauma, active gastric ulcer, or fracture within 4 weeks prior to enrollment.
18. Have a history of arterial thrombosis (including myocardial infarction and cerebral infarction) within 24 weeks before registration.
19. there is a history of deep vein thrombosis or pulmonary artery thrombosis (excluding catheter thrombosis and superficial thrombosis) within 12 weeks before registration.
20. Immune deficiency (such as HIV infection), autoimmune diseases with administration of systemic steroids.
21. Received antiplatelet drugs (clopidogrel, ticlopidine, dipyridamole, etc.). Low doses of aspirin (less than 325 mg / day) and non-steroidal anti-inflammatory drugs (NSAIDs) can be enrolled. If anticoagulant is administered for thrombosis that can be confirmed on the image, it is excluded. Anticoagulant therapy for the prevention of thrombosis with stable coagulation function (PT-INR less than facility standard upper limit x 1.5) for 12 weeks or more before registration, it is eligible.
22. There is continuous use of systemic steroids (excluding contrast agent allergy prophylaxis, pre-medication of anti-cancer agents, hydrocortisone replacement therapy for adrenal hypofunction of immune-related adverse events) and immunosuppressive agents.
23. HBsAg is positive. However, if it is controlled by a nucleic acid analog preparation and negative of HBV-DNA is confirmed, it can be registered.
24. Pregnant women, lactating women, women who may be pregnant or who are not willing to use contraception.
25. Difficult to enroll in this study due to a clinically problematic mental illness

Related Information

• Primary Sponsor: Hiroki Hara
• Secondary Sponsor: Naoki Takahashi,TAIHO PHARMACEUTICAL CO., LTD.