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

NCT07454031 | Not Yet Recruiting Phase 1

• 1 other identifier: SZBL-PX-PMA-001
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Peritoneal (Metastatic) Cancer

Keywords

peritoneal adenocarcinoma; PX; nab-paclitaxel; intraperitoneal injection·

Outcome Measures

Primary Outcomes (2)

• adverse events

  adverse events after treatment

  up to 21 days

• 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.

  up to 21 days

Study Arms (1)

PX in combination with nab-paclitaxel

EXPERIMENTAL

intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma

Drug: intraperitoneal PX in combination with nab-paclitaxel

Interventions

intraperitoneal PX in combination with nab-paclitaxel DRUG

intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma,

PX in combination with nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Shenzhen Bay Laboratory: collaborator

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lin Shen, Prof.

CONTACT

01088196088; oncogene@163.com

Jian Li, Dr.

CONTACT

861088196088; oncogene@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share