Pseudomyxoma Peritonei (PMP)
Conditions
Interventions
Safety Run-In Period, First 3 Subjects:intratumoral injection
For Subsequently Enrolled Subjects:intratumoral injection or intraperitoneal injection
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, male or female. 2. Patients with Pseudomyxoma Peritonei (PMP) confirmed by imaging and histopathology. 3. Deemed ineligible for Cytoreductive Surgery (CRS) ± Hyperthermic Intraperitoneal Chemotherapy (HIPEC) by the surgical team, OR have radiologically confirmed disease recurrence or progression after prior standard surgical treatment; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 5. Adequate organ function, meeting the following criteria (confirmed by laboratory tests within 7 days prior to enrollment):a. Hematology: Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, Platelet (PLT) >= 80 × 10^9/L, Hemoglobin (Hb)>= 85 g/L.b. Liver Function: Total Bilirubin (TBIL), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) = 50 mL/min (calculated by Cockcroft-Gault formula). d. Coagulation: Prothrombin Time (PT) = 3 months. 7. Meet at least ONE of the following administration criteria: a. Suitable for Intratumoral Injection: At least one measurable lesion meeting the following criteria on imaging (abdominal CT or ultrasound): Longest diameter of the tumor lesion = 3 cm, and a clear puncture path that safely avoids critical organs and major blood vessels. (Note: The first 3 subjects must meet the intratumoral injection criteria and will receive PX via intratumoral injection only). b. Suitable for Intraperitoneal Injection: Deemed suitable for safe, ultrasound-guided peritoneal catheter placement, with no contraindications such as extensive abdominal adhesions that would prevent drug distribution. 8. Voluntarily participate in the study, demonstrate understanding, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; OR subjects of childbearing potential (male or female) who plan to conceive (including sperm or egg donation) and/or are unwilling to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational product. 2. Imaging suggests tumor-induced or suspected gastrointestinal fistula, tumor invasion or proximity to high-risk areas such as major blood vessels, OR clinically judged severe gastrointestinal obstruction; 3. Known active bleeding, any uncorrected congenital or acquired coagulation disorder (e.g., hemophilia), OR requiring therapeutic anticoagulation that cannot be safely withheld prior to the study's interventional procedures, despite meeting the coagulation inclusion criteria. 4. Known history of allergy to PX, any analogous product, or any excipient in its formulation. 5. Severe or poorly controlled comorbidities or concurrent illnesses that, in the investigator's judgment, may increase the risk of participation or interfere with the evaluation of study results, including but not limited to: severe gastrointestinal diseases, uncontrolled hypertension, unstable angina, myocardial infarction or severe arrhythmia within 6 months prior to enrollment, severe active infection, clinically significant central nervous system disorders, etc. 6. History of definite active or prior severe autoimmune disease; OR currently receiving systemic immunosuppressive therapy (including but not limited to long-term use of corticosteroids, immunosuppressants, immunomodulators, or biologics). 7. Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or Human Immunodeficiency Virus antibody (HIV-Ab). 8. Any psychiatric or cognitive impairment that may significantly affect study compliance or interfere with the interpretation of study results. 9. Any other condition deemed by the investigator as inappropriate for participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE and SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the size of the injected lesion(s);and assessment of intratumoral liquefaction and liquefaction volume;EORTC QLQ-C30;Total volume of mucin aspirated/drained via catheter;total intra-abdominal mucin volume;Anti-drug antibodies;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactLi Ning
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed