计划状态
活跃，非招募阶段
第 1 阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
贝伐单抗、卡培他滨、腹腔注射奥沙利铂、阿瓦斯汀、依洛铂、Xeloda标签
MSS/ MMRp评论
一项以 CRC 为导向的新技术试验。
这项研究旨在测试腹膜内（IP）剂量*奥沙利铂与贝伐珠单抗和卡培他滨联合使用的递增剂量，是否适用于已进行充分细胞减灭术、腹腔扫描显示至少有一个腹腔穿刺孔通畅的*腹膜癌变（PC）*（由 CRC 引起）患者。
| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
华盛顿大学医学院 密苏里州圣路易斯市 63110 |
活跃，非招募 |
纳入标准
纳入标准
* Histological Diagnosis: Patients must have a histologically documented peritoneal carcinomatosis from either colorectal or appendiceal adenocarcinoma.
* Prior Surgical Debulking: Patients must have undergone debulking surgery with peritonectomy and have been allowed at least 4 weeks to recover prior to receiving chemotherapy.
* Port Placement: Intraperitoneal ports may be placed during or at any time separate from surgical debulking. Provided the patient has been allowed at least 4 weeks to recover from surgical debulking, no additional recovery time is required for port placement.
* Active port: Patients must undergo a peritoneal scan documenting at least one working intraperitoneal port prior to receiving chemotherapy.
* Patients may have received prior chemotherapy.
* Age: Patients must be ≥18 years of age. Because no dosing or toxicity data are currently available on the use of oxaliplatin in patients <18 years of age.
* Performance Status: (Eastern cooperativeOncology Group) ECOG 0-2.
* Recovery from Intercurrent Illness: Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmias.
* Informed Consent: All patients must be consented prior to chemotherapy. The patient should not have any serious medical of psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
* Hematological Status:
绝对中性粒细胞计数≥1,500 个/毫米³ * 血小板计数≥100,000 个/毫米
血小板计数≥100,000/mm³ * 血红蛋白≥8 g/dl
* 血红蛋白≥8 g/dl。
* 肝功能：
* Total bilirubin must be <2X the institutional upper limit of normal (ULN)
* Transaminases (SGOT and/or SGPT) must be ≤3X the institutional upper limit of normal (ULN)
* Alkaline phosphatase must be ≤4X the institutional upper limit of normal (ULN)
* Renal Function: Patients must have adequate renal function prior to chemotherapy defined as serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml.min/1.73 m² for patients with creatinine levels above 2.0 mg/dl.
排除标准
排除标准：
* 怀孕或哺乳：对于所有性活跃的患者，在治疗期间、进入研究之前以及参与研究期间，必须采取适当的避孕措施（激素或屏障避孕法）。所有有生育能力的女性均需确定未孕状态。
* 曾对奥沙利铂、贝伐单抗、5-FU 或卡培他滨有过敏反应。
* 可能会影响口服药物吸收的胃肠道疾病（如肠梗阻、短肠综合征）。
* 接受抗逆转录病毒治疗的艾滋病病毒感染者因可能发生药代动力学相互作用而不能参加本研究。如有必要，将对接受 HAART 治疗的患者进行适当的研究。
* 患有 2 级或以上周围神经病变的患者。
