Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma
Starting soon · Phase 1
Conditions studied: Peritoneal (Metastatic) Cancer
In brief
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).
Key facts
- Study ID
- NCT07454031
- Run by
- Peking University
- People needed
- 22
- Starts
- 2026-03-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.