Evaluating the effects of chemotherapy regimens on Pseudomyxoma Peritonei

Fluorouracil-labeled Nascent RNA Technology for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei

This study is testing whether different chemotherapy treatments can improve outcomes for people with Pseudomyxoma Peritonei by looking at how they affect tumor genes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06839378 on ClinicalTrials.gov

What this trial studies

This study aims to assess the impact of different hyperthermic intraperitoneal chemotherapy (HIPEC) regimens on the nascent transcriptome of Pseudomyxoma Peritonei (PMP) tumors. Participants diagnosed with PMP will be randomly assigned to receive either cisplatin or a combination of cisplatin and docetaxel during HIPEC treatment. Tumor tissue samples will be collected before and after treatment for high-throughput sequencing using Flura-seq technology to analyze changes in gene expression. The goal is to evaluate the efficacy of these regimens and identify potential new therapeutic targets for PMP.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed Pseudomyxoma Peritonei who are eligible for cytoreductive surgery and HIPEC.

Not a fit: Patients with severe allergies, systemic infections, or those unable to cooperate with treatment evaluation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could optimize chemotherapy regimens for patients with Pseudomyxoma Peritonei, potentially improving treatment outcomes.

How similar studies have performed: While the specific combination of Flura-seq and HIPEC for PMP is novel, similar approaches have shown promise in other cancer treatments.

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.

Where this trial is running

Beijing

• Beijing Tsinghua Changgung Hospital — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Yan Li, PhD — Beijing Tsinghua Changgeng Hospital
• Study coordinator: Yan Li, PhD

Conditions: Pseudomyxoma Peritonei, Flura-seq, PMP, HIPEC, Fluorouracil-labeled Nascent RNA Technology