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NCT07328737
One vs Three HIPEC Cycles After CRS for Pseudomyxoma Peritonei
NA trial testing One HIPEC session in Pseudomyxoma Peritonei in 132 participants. Currently enrolling.
1 November 2028
Quick facts
| Lead sponsor | Beijing Tsinghua Chang Gung Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 1 November 2025 |
| Primary completion | 1 November 2028 |
| Estimated completion | 1 November 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- One HIPEC session
- Three HIPEC sessions
Conditions studied
- Pseudomyxoma Peritonei — all drugs for Pseudomyxoma Peritonei →
Sponsor
Beijing Tsinghua Chang Gung Hospital
Who can join
Adults 18 to 70, any sex, with Pseudomyxoma Peritonei. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07328737
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Related trials
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Other Beijing Tsinghua Chang Gung Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07328737 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tsinghua Chang Gung Hospital
- Last refreshed: 9 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07328737.
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