jRCTs041240169招募中不适用
Phase 1 study of modified FOLFOXIRI in combination with molecular targeted therapy and immune checkpoint inhibitors for advanced gastric cancer (G-FOLFOXIRI)
未提供0 个研究点目标入组 63 人开始时间: 2025年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 63
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients have given written informed consent.
- •The age of patients on registration date is 18 years or older.
- •Patients have diagnosed with histologically adenocarcinoma (general type).
- •No signs of intestinal obstruction are observed.
- •The patients have unresectable advanced or recurrent gastric cancer.
- •The presence or absence of measurable lesions is not a criterion for inclusion.
- •No prior history of chemotherapy for gastric cancer.
- •No prior history of treatment with oxaliplatin.
- •ECOG Performance Status (PS) is 0-
- •The latest laboratory results within 7 days prior to enrollment meet all following criteria
- •(1) Neutrophil count>=1,500/mm3
- •(2) Hemoglobin >=8.0 g/dL (with no history of blood transfusion within the 7 days prior to the blood test for enrollment)
- •(3) Platelet count>=100,000/mm3
- •(4) Total bilirubin level =<1.5 mg/dL
- •(5) Aspartate aminotransferase (AST, GOT)=<100 IU/L
- •(6) Alanine aminotransferase (ALT, GPT)=<100 IU/L
- •(7) Serum creatinine =<1.5 mg/dL patients with a serum creatinine >1.5 mg/dL may be eligible if the creatinine clearance (CCr) is >=20 mL/min.
- •NIVO Cohort
- •HER2-negative or HER2 status is indeterminate.
- •HER2-negative or HER2 status is indeterminate.
- •CLDN18.2-positive.
- •Tmab Cohort
- •HER2-positive.
排除标准
- •Patients with concurrent cancer requiring treatment
- •Patients with symptomatic metastasis to the central nervous system (brain, spinal cord, or meninges)
- •Patients with ascites or pleural effusion requiring drainage
- •T Patients with a localized or systemic active infection that requires intervention
- •Patients with deemed unsuitable for enrollment due to a psychiatric disorder that could affect clinical trial participation
- •Patients with any of the following complications:
- •(1) Interstitial pneumonia/pulmonary fibrosis
- •(2) Positive for HBs antigen or HBV-DNA (patients on antiviral therapy for more than 1 week are eligible)
- •(3) Grade 2 or higher peripheral sensory neuropathy
- •Patients have undergone any of the following surgeries prior to treatment in this study:
- •(1) Major surgery involving resection or anastomosis of hollow organs within 14 days before the scheduled start date of study treatment, including laparotomy or laparoscopic surgery.
- •(2) Surgery involving a colostomy, exploratory laparotomy, or diagnostic laparoscopy within 7 days before the scheduled start date of study treatment.
- •Patients with a history of myocardial infarction or unstable angina within the last 6 months
- •Patients are pregnant, breastfeeding, possibly pregnant, or does not intend to use contraception
- •Patients with other significant medical abnormalities as judged by the investigator
- •NIVO Cohort
- •Patients who require systematic therapy including corticosteroid > 10 mg/day or other immunosuppressive agent within 14 days before registration.
- •Patients have a history of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulatory or checkpoint pathways.
- •Patients have a history of receiving anti-CLDN18.2 antibodies or other antibodies or drugs specifically targeting CLDN18.
- •Tmab Cohort
- •Patients have a history of receiving anti-HER2 antibodies or other antibodies or drugs specifically targeting HER
- •Patient's left ventricular ejection fractions are below 50% on echocardiography within 28 days prior to enrollment.
结局指标
主要结局
-
Incidence of Dose-Limiting Toxicity (DLT)
次要结局
未报告次要终点
研究者
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