Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501) - Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501)

Ishioka Chikashi0 个研究点目标入组 30 人开始时间: 2019年3月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) histologically confirmed as adenocarcinoma of the stomach
•2) One or more evaluable lesions confirmed by CT or other imaging within 28 days before the registration.
•3) ECOG performace status: 0-2.
•4) Received only one previous chemotherapeutic regimen which is 5-FU-based (inluding patients who had recurrence during or within 24 weeks after adjuvant chemotherapy)
•5) Estimated to survive for three months or more since registration.
•6) Written informed consent.
•7) Age 70 or above.
•8) Fulfill the following hematological and biochemical data obtained in the most recent blood and urine tests. Neutrophils >= 1,500 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dl, AST =< 100 IU/l, ALT =< 100 IU/l, total bilirubin =< 1.5 g/dl, and creatinie =< 1.5 in blood test, and urine protein <= 1+ or 2 g/day. Patients should not receive transfusion or granulocyte colony stimulating factor within 14 days before the blood test.
•9) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.

•1) Received taxane-based regimen.
•2) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer.
•3) Active infection and inflammation.
•4) Active hepatitis.
•5) Current or past history within 1 year of serious heart disease that requires hospitalization
•6) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis.
•7) Active gastrointestinal bleeding.
•8) Gastrointestinal perforation or histula, artelial embolism within 6 months or venous thromboembolism within 3 months before registration.
•9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs.
•10) Grade 2 or more neuropathy.
•11) Effusion that requires drainage.
•12) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.

发起方

Ishioka Chikashi