One vs Three HIPEC Cycles After CRS for Pseudomyxoma Peritonei

NCT07328737 | Recruiting

• 1 other identifier: 25814-4-02
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Control Group: Receive only a single intraoperative HIPEC session following CRS.
• 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).

Conditions

Pseudomyxoma Peritonei

Outcome Measures

Primary Outcomes (2)

• 1-year progression-free survival rate

  From randomization until 12 months postoperatively.

• serious adverse events incidence

  From randomization until 1 months postoperatively.

Secondary Outcomes (2)

• progression-free survival

  From randomization until 3 years postoperatively.

• Overall survival

  From randomization until 3 years postoperatively.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Procedure: Three HIPEC sessions

Control Group

ACTIVE COMPARATOR

Procedure: One HIPEC session

Interventions

One HIPEC session PROCEDURE

Receive only a single intraoperative HIPEC session following CRS.

Control Group

Three HIPEC sessions PROCEDURE

Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily consent to participate, sign informed consent, and be willing and able to comply with the study protocol;
• Age 18-70 years;
• Undergo CRS+HIPEC with pathological diagnosis of PMP of high grade with signet-ring cells, high grade, or low grade;
• Karnofsky performance status (KPS) \>60;
• Adequate function of major organs as follows:
• 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;
• Hepatic function: AST, ALT, and TBIL ≤2×upper limit of normal (ULN);
• Renal function: serum creatinine \<1.2×ULN;
• Coagulation: APTT ≤1.5×ULN; INR or PT ≤1.5×ULN;
• 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;

You may not qualify if:

• Metastases to lung, brain, bone, or liver;
• AST, ALT, or TBIL ≥2×ULN;
• Serum creatinine ≥1.2×ULN;
• Severe mesenteric contraction;
• Major organ dysfunction that cannot support the planned procedures;
• Concomitant hematological disorders or other malignancies;
• Acute or subacute infectious disease;
• History of allergy to cisplatin or docetaxel, or marked allergic diathesis or severe allergy history;
• Psychiatric or psychological disorders preventing cooperation with treatment and efficacy evaluation;
• Any other condition deemed unsuitable for enrollment by the investigator;

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Tsinghua University affiliated Beijing Tsinghua Changgung Hospital

Beijing, Changping, 102218, China

RECRUITING

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Central Study Contacts

Rui Yang

CONTACT

+8615600502066; mw1025170732@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology and Director of the Department of Peritoneal Oncology

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

CN (1)