One versus three HIPEC cycles after cytoreductive surgery for pseudomyxoma peritonei

Efficacy and Safety of One vs Three Cycles of Hyperthermic Intraperitoneal Chemotherapy After Cytoreductive Surgery for Pseudomyxoma Peritonei: A Multicenter Randomized Controlled Study

This study will see if giving three HIPEC sessions instead of one after cytoreductive surgery helps people with pseudomyxoma peritonei live longer, delay disease progression, and keep a better quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Changping)
• Trial ID: NCT07328737 on ClinicalTrials.gov

What this trial studies

Patients with pseudomyxoma peritonei who undergo cytoreductive surgery are randomly assigned to receive either a single intraoperative HIPEC session or three HIPEC sessions. The trial compares progression-free survival and overall survival between the two groups and tracks postoperative complications, organ toxicity, and patient-reported quality of life. Key eligibility includes age 18–70, adequate organ function, Karnofsky performance status >60, and a radiologic peritoneal cancer index ≥15. The study is conducted at Beijing Tsinghua Changgung Hospital with follow-up to capture survival, adverse events, and quality-of-life outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–70 with pathologically confirmed pseudomyxoma peritonei who can tolerate major surgery and HIPEC, have adequate organ function, KPS >60, and a PCI of at least 15.

Not a fit: Patients with poor performance status, significant organ dysfunction, inability to tolerate major surgery or HIPEC, or who do not meet the age and laboratory criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If additional HIPEC sessions are beneficial, patients could experience longer progression-free and overall survival or clearer guidance on acceptable toxicity from extended HIPEC therapy.

How similar studies have performed: Cytoreductive surgery followed by a single HIPEC session is an established approach for PMP, but direct randomized comparison of one versus three HIPEC sessions is novel and has limited prior data.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily consent to participate, sign informed consent, and be willing and able to comply with the study protocol;
2. Age 18-70 years;
3. Undergo CRS+HIPEC with pathological diagnosis of PMP of high grade with signet-ring cells, high grade, or low grade;
4. Karnofsky performance status (KPS) \>60;
5. 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 ≤2×upper limit of normal (ULN);
   3. Renal function: serum creatinine \<1.2×ULN;
   4. Coagulation: APTT ≤1.5×ULN; INR or PT ≤1.5×ULN;
   5. Cardiopulmonary function sufficient to tolerate major surgery and HIPEC;

(5) Radiological Peritoneal Cancer Index (PCI) ≥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:

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;

Where this trial is running

Beijing, Changping

• Tsinghua University affiliated Beijing Tsinghua Changgung Hospital — Beijing, Changping, China (Recruiting)

Study contacts

• Study coordinator: Rui Yang

Conditions Pseudomyxoma Peritonei