N/A
N=36
Flura-seq for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei
Pseudomyxoma Peritonei
Bottom Line
View on ClinicalTrials.gov: NCT06839378 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Changes in RNA in Tumor Tissues Before and After HIPEC — 1413; 1927 Numbers of changed RNA
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intravenously inject with 5-FU (400 mg/m2) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beijing Tsinghua Chang Gung Hospital
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in RNA in Tumor Tissues Before and After HIPEC |
1413; 1927 | — |
| SECONDARY Comparison of Transcriptomic Changes Detected by Flura-seq vs. Bulk RNA-seq |
1,690; 340 | — |
Summary
The main objective of this study is to combine HIPEC regimens with Flura-seq to detect the effects of different HIPEC regimens (cisplatin vs. cisplatin+ docetaxel) on the nascent transcriptome of PMP tumors, so as to quantitatively assess the efficacy of different HIPEC regimens in the early stage, and to lay the foundation for optimizing the HIPEC regimens and exploring new therapeutic targets.
Eligibility Criteria
Inclusion Criteria
- Age 18-75 years old, regardless of gender and race;
- Pathologically confirmed as pseudomyxoma peritonei; acceptable for CRS+HIPEC treatment;
- KPS score ≥ 60, with expected survival time more than 12 months;
- The functions of important organs are basically normal, with no significant abnormalities in liver or kidney function;
- No history of allergy to biological products;
- No serious bacterial or viral infection;
- Non-pregnancy and lactation;
- The patient or his/her delegate understands and cooperates with the treatment and signs the informed consent for the treatment.
Exclusion Criteria
- Highly allergic or with a history of severe allergies, especially to biological products;
- Shock, systemic failure, unstable vital signs, and inability to cooperate with the examination;
- Those who have mental or psychological diseases and cannot cooperate with treatment and curative effect evaluation;
- T-lymphocyte carcinoma/tumor;
- Patients with systemic infection or severe local infection requiring anti-infection treatment;
- Complicated with dysfunction of heart, lung, brain, kidney, liver and other important organs;
- Coagulation disorders (e.g., hemophilia);
- Infectious diseases (e.g. HIV, RPR, active TB, etc.);
- Pregnant or lactating women, or women who have pregnancy plans within half a year;
- Patients who are taking immunosuppressive drugs or long-term anti-rejection drugs after organ transplantation;
- Patients with severe autoimmune diseases;
- Any life-threatening disease, physical condition or organ system dysfunction that the researcher believes may damage the safety of subjects and expose the research results to unnecessary risks; Drug-dependent persons;
- Patients and/or authorized family members who refuse or do not actively sign the informed consent;
- Participants in other clinical studies within 3 months.
Data sourced from ClinicalTrials.gov (NCT06839378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.