One versus three HIPEC cycles after cytoreductive surgery for pseudomyxoma peritonei

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
  Beijing, Changping, China Recruiting

Study contacts

• Study coordinator: Rui Yang
• Email: mw1025170732@163.com
• Phone: +8615600502066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Appendix Cancer and PMP Patient Registry and Natural History Study

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• Metformin in PMP from appendiceal mucinous neoplasms

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• Pseudovax: a vaccine for people with pseudomyxoma peritonei

  This trial will test whether the Pseudovax peptide vaccine with GM‑CSF plus the PD‑1 drug tislelizumab can boost anti‑tumor immunity in adults with GNAS‑mutated pseudomyxoma peritonei.

  Recruiting Early Phase 1 Oslo University Hospital · Oslo, Oslo · NCT07341360

• Neoadjuvant treatment for patients with advanced Pseudomyxoma peritonei

  This study is testing a new combination of medications to see if it can help patients with advanced Pseudomyxoma peritonei have better surgery results.

  Recruiting Phase 2 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Milan · NCT06800391

• Comparing low-dose and high-dose chemotherapy for treating Pseudomyxoma Peritonei

  This study is testing if a lower dose of chemotherapy given for a shorter time can work just as well as a higher dose for treating Pseudomyxoma Peritonei.

  Recruiting Phase 3 University of Southampton · Basingstoke, Hampshire · NCT06513065

• Using cardiac coherence to reduce anxiety in patients with peritoneal carcinosis before surgery

  This study is testing if teaching patients with peritoneal carcinosis some breathing techniques can help reduce their anxiety before surgery.

  Recruiting Institut du Cancer de Montpellier - Val d'Aurelle · Montpellier, Hérault · NCT04024917

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.