Clinical trial · Interventional
Flura-seq for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei
Fluorouracil-labeled Nascent RNA Technology for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intravenously inject with 5-FU (400 mg/m2) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cisplatin Group
- description
- After completing CRS, the patient will undergo cisplatin HIPEC treatment. Add 120 mg of cisplatin to 3000 ml of physiological saline, heat to 43 ℃, perfuse at a flow rate of 400 ml/min, and perfuse for 60 minutes.
- interventionNames
- Procedure: intravenously inject with 5-FU (400 mg/m2)
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin + Docetaxel Group
- description
- After completing CRS, the patient will undergo HIPEC treatment with cisplatin and docetaxel. Add 120 mg of docetaxel and 120 mg of cisplatin to 3000 ml of physiological saline, heat to 43 ℃, perfuse at a flow rate of 400 ml/min, and perfuse for 60 minutes.
- interventionNames
- Procedure: intravenously inject with 5-FU (400 mg/m2)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDWang Q, Lu F, Lan R. RNA-sequencing dissects the transcriptome of polyploid cancer cells that are resistant to combined treatments of cisplatin with paclitaxel and docetaxel. Mol Biosyst. 2017 Sep 26;13(10):2125-2134. doi: 10.1039/c7mb00334j. PMID 28825433
- BACKGROUNDMehta AM, Huitema AD, Burger JW, Brandt-Kerkhof AR, van den Heuvel SF, Verwaal VJ. Standard Clinical Protocol for Bidirectional Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Systemic Leucovorin, 5-Fluorouracil, and Heated Intraperitoneal Oxaliplatin in a Chloride-Containing Carrier Solution. Ann Surg Oncol. 2017 Apr;24(4):990-997. doi: 10.1245/s10434-016-5665-6. Epub 2016 Nov 28. PMID 27896510
- BACKGROUNDBasnet H, Tian L, Ganesh K, Huang YH, Macalinao DG, Brogi E, Finley LW, Massague J. Flura-seq identifies organ-specific metabolic adaptations during early metastatic colonization. Elife. 2019 Mar 26;8:e43627. doi: 10.7554/eLife.43627. PMID 30912515
- BACKGROUNDFernandez RN, Daly JM. Pseudomyxoma peritonei. Arch Surg. 1980 Apr;115(4):409-14. doi: 10.1001/archsurg.1980.01380040037006. PMID 7362446
- BACKGROUNDChua TC, Moran BJ, Sugarbaker PH, Levine EA, Glehen O, Gilly FN, Baratti D, Deraco M, Elias D, Sardi A, Liauw W, Yan TD, Barrios P, Gomez Portilla A, de Hingh IH, Ceelen WP, Pelz JO, Piso P, Gonzalez-Moreno S, Van Der Speeten K, Morris DL. Early- and long-term outcome data of patients with pseudomyxoma peritonei from appendiceal origin treated by a strategy of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. J Clin Oncol. 2012 Jul 10;30(20):2449-56. doi: 10.1200/JCO.2011.39.7166. Epub 2012 May 21. PMID 22614976
- BACKGROUNDHinson FL, Ambrose NS. Pseudomyxoma peritonei. Br J Surg. 1998 Oct;85(10):1332-9. doi: 10.1046/j.1365-2168.1998.00882.x. PMID 9782010
- BACKGROUNDCarr NJ, Cecil TD, Mohamed F, Sobin LH, Sugarbaker PH, Gonzalez-Moreno S, Taflampas P, Chapman S, Moran BJ; Peritoneal Surface Oncology Group International. A Consensus for Classification and Pathologic Reporting of Pseudomyxoma Peritonei and Associated Appendiceal Neoplasia: The Results of the Peritoneal Surface Oncology Group International (PSOGI) Modified Delphi Process. Am J Surg Pathol. 2016 Jan;40(1):14-26. doi: 10.1097/PAS.0000000000000535.