Clinical trial · Interventional
Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma
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
NCT07454031CI-TRIAL-00105417not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal (Metastatic) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraperitoneal PX in combination with nab-paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PX in combination with nab-paclitaxel
- description
- intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma
- interventionNames
- Drug: intraperitoneal PX in combination with nab-paclitaxel
Primary outcomes (2)
- measure
- adverse events
- timeFrame
- up to 21 days
- description
- adverse events after treatment
- measure
- the maximum tolerated dose
- timeFrame
- up to 21 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.