About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- intraperitoneal PX in combination with nab-paclitaxel
Treatment groups
Locations
Sponsors and collaborators
Peking University
Lead sponsor
Shenzhen Bay Laboratory
Collaborator