Pseudomyxoma PeritoneiNCT07328737
One vs Three HIPEC Cycles After CRS for Pseudomyxoma Peritonei
A study testing One HIPEC session and Three HIPEC sessions in people with Pseudomyxoma Peritonei, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pseudomyxoma Peritonei
- What is being tested?
- One HIPEC session and Three HIPEC sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Beijing, Changping, 102218
Rui Yang, +8615600502066, mw1025170732@163.com
About this study
Official title: 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:
Read more
- 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
- Being tested
- One HIPEC session, Three HIPEC sessions
- Medical subject headings
- Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One HIPEC sessionProcedure or surgery
Receive only a single intraoperative HIPEC session following CRS.
Three HIPEC sessionsProcedure or surgery
Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Procedure: Three HIPEC sessions |
| Control Group | Active comparator | Not described Receives: Procedure: One HIPEC session |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival rate
Measured: From randomization until 12 months postoperatively.
serious adverse events incidence
Measured: From randomization until 1 months postoperatively.
Secondary outcomes (2)
progression-free survival
Measured: From randomization until 3 years postoperatively.
Overall survival
Measured: From randomization until 3 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328737
- Sponsor's protocol ID
- 25814-4-02
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of One vs Three Cycles of Hyperthermic Intraperitoneal Chemotherapy After Cytoreductive Surgery for Pseudomyxoma Peritonei: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07328737
- Acronym / sponsor ID
- 25814-4-02
- Conditions
- Pseudomyxoma Peritonei
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Three HIPEC sessions |
| Control Group | Active comparator | Procedure: One HIPEC session |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One HIPEC sessionReceive only a single intraoperative HIPEC session following CRS. | Procedure or surgery | Control Group |
| Three HIPEC sessionsReceive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses. | Procedure or surgery | Experimental Group |
Primary outcome
1-year progression-free survival rate
Time frame: From randomization until 12 months postoperatively.
serious adverse events incidence
Time frame: From randomization until 1 months postoperatively.
2 secondary outcomes
progression-free survival
Time frame: From randomization until 3 years postoperatively.
Overall survival
Time frame: From randomization until 3 years postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One HIPEC session and Three HIPEC sessions in people with Pseudomyxoma Peritonei, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Yang (+8615600502066, mw1025170732@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival rate (time frame: From randomization until 12 months postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.