One vs Three HIPEC Cycles After CRS for Pseudomyxoma Peritonei

NCT ID: NCT07328737

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2030-11-01

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:

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).

Conditions

Pseudomyxoma Peritonei

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Group Type: EXPERIMENTAL

Three HIPEC sessions

Intervention Type: PROCEDURE

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

Control Group

Group Type: ACTIVE_COMPARATOR

One HIPEC session

Intervention Type: PROCEDURE

Receive only a single intraoperative HIPEC session following CRS.

Interventions

One HIPEC session

Receive only a single intraoperative HIPEC session following CRS.

Intervention Type: PROCEDURE

Three HIPEC sessions

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

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yan Li

Professor of Oncology and Director of the Department of Peritoneal Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tsinghua University affiliated Beijing Tsinghua Changgung Hospital

Beijing, Changping, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Yang

Role: CONTACT

mw1025170732@163.com

+8615600502066

Facility Contacts

Rui Yang

Role: primary

mw1025170732@163.com

+8615600502066

Other Identifiers

25814-4-02

Identifier Type: -

Identifier Source: org_study_id