Pseudomyxoma peritonei
Conditions
Interventions
Experimental group:Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses.
Control group:Receive only a single intraoperative HIPEC session following CRS.
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily consent to participate, sign informed consent, and be willing and able to comply with the study protocol;Age 18–70 years; 2.Undergo CRS+HIPEC with pathological diagnosis of PMP of high grade with signet-ring cells, high grade, or low grade; 3.Karnofsky performance status (KPS) >60; 4.Adequate function of major organs as follows: (1)Hematology: WBC >=3.5×10^9/L, ANC >=1.0×10^9/L, LC >=0.5×10^9/L, PLT >=80×10^9/L, Hb >=90 g/L; (2)Hepatic function: AST, ALT, and TBIL =15; 6.No local or systemic antitumor therapy within 1 month prior to CRS+HIPEC; 7.Adverse reactions from prior treatments have resolved before study initiation or, in the investigator’s judgment, will not interfere with this study.
Exclusion criteria
Exclusion criteria: 1. Metastases to lung, brain, bone, or liver; 2. AST, ALT, or TBIL >=2×ULN; 3. Serum creatinine >=1.2×ULN; 4. Severe mesenteric contraction; 5. Major organ dysfunction that cannot support the planned procedures; 6. Concomitant hematological disorders or other malignancies; 7. Acute or subacute infectious disease; 8. History of allergy to cisplatin or docetaxel, or marked allergic diathesis or severe allergy history; 9. Psychiatric or psychological disorders preventing cooperation with treatment and efficacy evaluation; 10. Any other condition deemed unsuitable for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival rate;SAE incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survial; | — |
Countries
China
Contacts
Public ContactYan Li
Beijing Tsinghua Changgung Hospital, Tsinghua University
Outcome results
None listed