JPRN-jRCTs031230127招募中1 期
Phase I/II study to evaluate the safety and efficacy of the combination of S-1 + oxaliplatin + nivolumab, including the optimal dose of S-1 based on the BBT formula, in HER2-negative unresectable and advanced recurrent gastric cancer
Suzuki Nobumi0 个研究点目标入组 20 人开始时间: 2023年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) histologically diagnosed as HER2-negative adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma), ring cell carcinoma, mucous carcinoma.
- •No prior chemotherapy for gastric cancer. Patients with recurrent cancer after 180 days from the last day of preoperative or postoperative adjuvant chemotherapy are eligible for enrollment. 3.
- •Patients who are judged to be eligible for combination therapy with SOX and nivolumab by the physician in charge of the patient. 4.
- •4. the S-1 dose obtained from the BBT formula nomogram (page X) is increased from the starting dose described in the package insert.
- •5. the patient is at least 18 years of age at the time consent is obtained.
- •6. ECOG-Performance Status is 0,1
- •7. Capable of oral intake
- •8. Have at least one evaluable lesion on contrast-enhanced CT (chest, abdomen, pelvis: slice thickness less than 7 mm) within 28 days prior to registration.
- •9. Clinical laboratory tests performed within 14 days prior to enrollment meet the following criteria:
- •Neutrophil count over 1,500 /mm3
- •Platelet count over 10x104 /mm3
- •Hemoglobin over 8.0 g/dL
- •AST (GOT) under 100 U/L (under 200 U/L in case of liver metastasis)
- •ALT (GPT) under 100 U/L (under 200 U/L in case of liver metastasis)
- •Total bilirubin under 1.5 mg/dL
- •Creatinine under 1.5 mg/dL
- •10. Patients with agree to contraception.
- •11. Patient has given written consent to participate in the study.
排除标准
- •1) Her2-positive gastric cancer (IHC: 3plus or IHC: 2plus with positive ISH)
- •2) Receiving enteral or intravenous nutritional support or requiring continuous infusion therapy
- •3) Patient has pericardial, pleural, or ascites fluid requiring drainage. However, if the fluid can be controlled by oral medication alone, it is acceptable.
- •4) Grade 2 or higher peripheral neuropathy
- •5) Brain or meningeal metastases. 5) Patients with brain or meningeal metastases, but brain imaging is not required for asymptomatic patients who do not require treatment.
- •6) Have multiple cancers (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and other cancers that have not recurred for at least 5 years)
- •7) Received any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or other T-cell regulating antibody or pharmacologic therapy
- •8) Current or past severe hypersensitivity to other antibody drugs
- •9) Has a concomitant autoimmune disease or a history of autoimmune disease.
- •Patients with type 1 diabetes mellitus, hypothyroidism manageable with hormone replacement, and dermatological diseases not requiring systemic treatment (vitiligo, psoriasis, alopecia, etc.) may be enrolled.
- •10) Patients with complications or history of interstitial lung disease or pulmonary fibrosis: diagnosis must be based on CT findings
- •11) Patients with concomitant diverticulitis or symptomatic gastrointestinal ulcerative disease
- •12) Using warfarin, phenytoin, or flucytosine at the time of enrollment
- •13) Received or required systemic corticosteroids (except for temporary use for testing, prevention of allergic reactions, or reduction of edema due to radiation therapy) or immunosuppressive drugs within 28 days prior to enrollment
- •14) Have transient ischemic attack, cerebrovascular disease, thrombosis, or thromboembolism (pulmonary arterial embolism, deep vein thrombosis) within 180 days prior to enrollment.
- •15) History of any of the following cardiac diseases Myocardial infarction within 180 days prior to enrollment Uncontrolled angina pectoris within 180 days prior to study enrollment New York Heart Association (NYHA) Class3 or 4 congestive heart failure
- •16) Uncontrolled diabetes mellitus
- •17) Systemic infection requiring treatment
- •18) Underwent surgery (any surgery involving general anesthesia) within 28 days prior to enrollment
- •19) Had radiotherapy for gastric cancer within 28 days prior to enrollment or radiotherapy for bone metastases within 14 days prior to enrollment
- •20) Received radiopharmaceuticals within 56 days prior to enrollment (except for use of radiopharmaceuticals for laboratory or diagnostic purposes)
- •21) Received other unapproved drugs within 28 days (90 days for antibody drugs) prior to study enrollment
- •22) Positive for human immunodeficiency virus-1 (HIV-1), human immunodeficiency virus-2 (HIV-2), human T lymphotropic virus-1 (HTLV-1), hepatitis B surface protein (HBs) antigen, or hepatitis C virus (HCV) antibody
- •23) HBs antigen negative but HBs or HBc antibody positive with detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA)
- •24) Pregnant, lactating, or possibly pregnant
- •25) Unable to give consent for specific reasons, such as concomitant dementia
- •26) Has received a live/weakly toxic vaccine within 28 days prior to study enrollment
- •27) Other individuals deemed inappropriate to participate in this study by the Principal Investigator(s)
研究者
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