Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Muci… (NCT07454031) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma
22 participantsStarted 2026-03-15
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 sen…