Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University

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

22 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Peking University

Lead sponsor

Shenzhen Bay Laboratory

Collaborator