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

March 11, 2026 updated by: Shen Lin, Peking University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Active or severe autoimmune disease, or ongoing systemic immunosuppressive therapy;
  • Positive for HBsAg, anti-HCV, syphilis antibody, or HIV antibody;
  • Psychiatric or cognitive disorders affecting compliance;
  • Any other condition deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PX in combination with nab-paclitaxel
intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma
Drug: intraperitoneal PX in combination with nab-paclitaxel
intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: up to 21 days
adverse events after treatment
up to 21 days
the maximum tolerated dose
Time Frame: 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.
up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Shenzhen Bay Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZBL-PX-PMA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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