One vs Three HIPEC Cycles After CRS 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

The goal of this clinical trial is to compare the efficacy and safety of one versus three sessions of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) for patients with pseudomyxoma peritonei (PMP).

The main questions it aims to answer are:

• Does receiving three HIPEC sessions lead to better Progression-Free Survival (PFS) and Overall Survival (OS) compared to one session?
• What are the differences in postoperative complications (e.g., infection, bowel obstruction, myelosuppression) and organ toxicity (e.g., liver/kidney injury) between the two regimens?
• How do the different treatment schedules impact patients' quality of life?

Researchers will compare the experimental group (3 HIPEC sessions) to the control group (1 HIPEC session) to investigate the efficacy and safety of the additional sessions.

Participants will:

• Be randomly assigned to one of two groups:

  1. Control Group: Receive only a single intraoperative HIPEC session following CRS.
  2. Experimental Group: Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses.
• Undergo scheduled safety checks for side effects on days 1, 3, 5, 7, and 10 post-HIPEC.
• Attend a follow-up visit at 1 month after CRS+HIPEC and, if eligible, receive 6 cycles of standard postoperative chemotherapy.
• Attend regular long-term follow-up visits for several years, which will include physical examinations, blood tests (for tumor markers), CT scans, and quality-of-life questionnaires (EORTC QLQ-C30 version 3.0).

Study Overview

• Status: Recruiting
• Conditions: Pseudomyxoma Peritonei
• Intervention / Treatment: Procedure: Three HIPEC sessions; Procedure: One HIPEC session

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rui Yang; Phone Number: +8615600502066; Email: mw1025170732@163.com

Study Locations

• China
  • Changping
    • Beijing, Changping, China, 102218
      • Recruiting
      • Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
      • Contact: Rui Yang; Phone Number: +8615600502066; Email: mw1025170732@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Procedure: Three HIPEC sessions; Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses.
Active Comparator: Control Group	Procedure: One HIPEC session; Receive only a single intraoperative HIPEC session following CRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year progression-free survival rate	From randomization until 12 months postoperatively.
serious adverse events incidence	From randomization until 1 months postoperatively.

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	From randomization until 3 years postoperatively.
Overall survival	From randomization until 3 years postoperatively.

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Neoplasms, Cystic, Mucinous, and Serous; Adenocarcinoma, Mucinous; Pseudomyxoma Peritonei
• Other Study ID Numbers: 25814-4-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No