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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One HIPEC session | Procedure | Receive only a single intraoperative HIPEC session following CRS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year progression-free survival rate | From randomization until 12 months postoperatively. | |
| serious adverse events incidence | From randomization until 1 months postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | From randomization until 3 years postoperatively. | |
| Overall survival | From randomization until 3 years postoperatively. |
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Inclusion Criteria:
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:
(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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Yang | Contact | +8615600502066 | mw1025170732@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsinghua University affiliated Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Changping | 102218 | China |
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| ID | Term |
|---|---|
| D011553 | Pseudomyxoma Peritonei |
| ID | Term |
|---|---|
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| Three HIPEC sessions | Procedure | Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses. |
|
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |