Flura-seq for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei

Last updated: February 21, 2025
Sponsor: Beijing Tsinghua Chang Gung Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

intravenously inject with 5-FU (400 mg/m2)

Clinical Study ID

NCT06839378
24753-0-02
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Age 18-75 years old, regardless of gender and race;

  • Pathologically confirmed as pseudomyxoma peritonei; acceptable for CRS+HIPECtreatment;

  • KPS score ≥ 60, with expected survival time more than 12 months;

  • The functions of important organs are basically normal, with no significantabnormalities 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 andsigns the informed consent for the treatment.

Exclusion

Exclusion Criteria:

  • Highly allergic or with a history of severe allergies, especially to biologicalproducts;

  • Shock, systemic failure, unstable vital signs, and inability to cooperate with theexamination;

  • Those who have mental or psychological diseases and cannot cooperate with treatmentand curative effect evaluation;

  • T-lymphocyte carcinoma/tumor;

  • Patients with systemic infection or severe local infection requiring anti-infectiontreatment;

  • Complicated with dysfunction of heart, lung, brain, kidney, liver and otherimportant 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 drugsafter organ transplantation;

  • Patients with severe autoimmune diseases;

  • Any life-threatening disease, physical condition or organ system dysfunction thatthe researcher believes may damage the safety of subjects and expose the researchresults to unnecessary risks; Drug-dependent persons;

  • Patients and/or authorized family members who refuse or do not actively sign theinformed consent;

  • Participants in other clinical studies within 3 months.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: intravenously inject with 5-FU (400 mg/m2)
Phase:
Study Start date:
February 17, 2025
Estimated Completion Date:
February 17, 2027

Study Description

  1. Participants:

    ① Diagnosed PMP patients;

    ② Patients can receive CRS+HIPEC treatment.

  2. Trial protocol: the patients will be randomly divided into cisplatin group and cisplatin + docetaxel group. Preoperative intravenous bolus injection of 5-FU (400 mg/m2) will be given before CRS+HIPEC treatment. After CRS, the patients will be treated with cisplatin or cisplatin + docetaxel HIPEC, respectively. Cisplatin 120 mg or docetaxel 120 mg + Cisplatin 120 mg will be added to 3,000 ml of saline, heated to 43 ℃, and perfused at a flow rate of 400 ml/min for 60 min.

  3. Sample collection: tumor tissue samples (5-10 g) will be collected before and after HIPEC treatment, and will be stored at 80 ℃ for nascent transcriptome sequencing.

  4. Sequencing analysis of nascent transcriptome: using high-throughput sequencing technology, the RNA extracted from tumor tissue samples before and after treatment with cisplatin or cisplatin + docetaxel HIPEC will be sequenced by Flura-seq to analyze the changes of newly synthesized transcripts in tumor tissue during HIPEC.

  5. Data analysis: the sequencing data will be processed and analyzed by bioinformatics methods. The differentially expressed genes in cisplatin group and cisplatin + docetaxel group will be compared to evaluate the efficacy of different HIPEC regimens on PMP. Functional annotation and pathway analysis of differentially expressed genes will be performed to explore molecular therapeutic targets for PMP-specific RNA.

  6. Treatment regimen for poor therapeutic effect: the study will not change the patient's existing HIPEC regimen. If the results show that HIPEC is not effective in treating the patient, it means that the drug is not effective for the patient during subsequent chemotherapy, and the chemotherapy regimen can be adjusted accordingly based on the Flura-seq results.

Connect with a study center

  • Beijing Tsinghua Changgung Hospital

    Beijing,
    China

    Active - Recruiting

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