An Investigator-Initiated Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Peking University
- 入组人数
- 22
- 主要终点
- adverse events
概览
简要总结
To evaluate the safety and tolerability of intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, regardless of sex;
- •Histologically confirmed peritoneal metastatic mucinous adenocarcinoma;
- •Considered suitable for intraperitoneal therapy based on investigator assessment;
- •ECOG performance status 0-2;
- •Adequate organ function confirmed by laboratory tests within 7 days prior to enrollment:
- •Hematology: ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 85 g/L; Liver function: TBIL ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome);AST/ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases); Renal function: creatinine clearance ≥ 60 mL/min (Cockcroft-Gault) or serum creatinine ≤ 1.5 × ULN; Coagulation: PT, INR, and APTT ≤ 1.5 × ULN;
- •Life expectancy ≥ 3 months;
- •Ability to understand and willingness to sign written informed consent.
排除标准
- •Planned concomitant systemic anti-tumor therapy during intraperitoneal treatment;
- •Massive ascites not expected to be adequately drained prior to dosing;
- •Chemotherapy or radiotherapy within 4 weeks prior to enrollment (≥ 6 weeks for nitrosoureas or mitomycin C);
- •Pregnancy or lactation, or unwillingness to use effective contraception;
- •Severe abdominal infection or gastrointestinal obstruction;
- •Known peritoneal adhesions deemed unsuitable for catheter placement;
- •Active bleeding, uncorrected coagulation disorders, or inability to safely interrupt therapeutic anticoagulation;
- •Known hypersensitivity to PX, nab-paclitaxel, or excipients;
- •Pre-existing ≥ Grade 2 peripheral sensory neuropathy;
- •Severe or uncontrolled comorbidities that may increase study risk or interfere with evaluation;
研究组 & 干预措施
PX in combination with nab-paclitaxel
intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma
干预措施: intraperitoneal PX in combination with nab-paclitaxel (Drug)
结局指标
主要结局
adverse events
时间窗: up to 21 days
adverse events after treatment
the maximum tolerated dose
时间窗: up to 21 days
Each dose level will initially enroll 3 participants. If 1 of 3 participants experiences a DLT, the cohort will be expanded to 6 participants. If ≤1 of 6 participants experiences a DLT, dose escalation will proceed. If ≥2 participants experience DLTs, the dose level will be considered above the MTD, and the previous dose level will be used as the primary reference for RP2D determination.
次要结局
未报告次要终点
研究者
Shen Lin
Prof.
Peking University