KCT0005753
Not yet recruiting
未知
Phase II study of pembrolizumab plus ramucirumab in metastatic gastric or GEJ adenocarcinoma as salvage treatment
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 35
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The patient is \=18 years of age.
- •2\.The patient who has received an adequate information and provided informed consent for all the study\-specific procedures in advance
- •3\.The patient has histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma. (Patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) patient has metastatic disease or locally recurrent, unresectable disease.
- •4\.The patient’s tumor tissue must have the pre\-defined characteristics as follows ; EBV\+ or PDL1 CPS\=10
- •5\.The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1\.1\)
- •6\. The patient has experienced disease progression during first\-line treatment or second\-line therapy for metastatic disease
- •Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum and/or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5\-FU, capecitabine, or S\-1\). Regimens including a third agent, such as an anthracycline or a taxane, are acceptable provided a fluoropyrimidine and/or a platinum were used.
- •Recurrence during or within 6 months of completion of adjuvant chemotherapy (capecitabine, 5\-FU, or TS\-1\) will be considered as first\-line chemotherapy.
- •7\.No prior exposure to anti\-PD1 antibody or ramucirumab
- •8\.The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1\.
Exclusion Criteria
- •1\.The patient has documented and/or symptomatic encephalitis, brain or leptomeningeal metastases.
- •2\.The patient has experienced any Grade 3 to 4 GI bleeding within 3 months prior to enrollment.
- •3\.The patient has experienced myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment.
- •4\.The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant”) during the 3 months prior to first dose of protocol therapy.
- •5\.The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the treating physician.
- •6\.The patient has ongoing or active psychiatric illness or social situation that would limit compliance with treatment
- •7\.The patient has uncontrolled or poorly controlled hypertension (\>160 mmHg systolic or
- •\>100 mmHg diastolic for \>4 weeks) despite standard medical management.
- •8\.The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
- •9\.The patient has received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to enrollment.
Outcomes
Primary Outcomes
Not specified
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