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).
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;
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;
Single group
intraperitoneal PX in combination with nab-paclitaxel
Drugintraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma,
adverse events
adverse events after treatment
the maximum tolerated dose
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.
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Peking University
Lead sponsor
Shenzhen Bay Laboratory
Collaborator
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