Peritoneal (Metastatic) Cancer
Conditions
Keywords
peritoneal adenocarcinoma, PX, nab-paclitaxel, intraperitoneal injection·
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).
Interventions
DRUGintraperitoneal PX in combination with nab-paclitaxel
intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma,
Sponsors
Peking University
Shenzhen Bay Laboratory
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | up to 21 days | adverse events after treatment |
| the maximum tolerated dose | up to 21 days | 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. |
Contacts
CONTACTLin Shen, Prof.
CONTACTJian Li, Dr.
Outcome results
None listed