Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intraperitoneal PX in combination with nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Peritoneal (Metastatic) Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Drug intraperitoneal PX in combination with nab-paclitaxel
intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma,
Primary outcome measures
- adverse events [Time frame: up to 21 days]
- the maximum tolerated dose [Time frame: up to 21 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07454031 · SZBL-PX-PMA-001