Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tsinghua University | OTHER |
Not provided
Not provided
Not provided
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.
Participants:
① Diagnosed PMP patients;
② Patients can receive CRS+HIPEC treatment.
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.
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.
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.
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin Group | Experimental | 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. |
|
| Cisplatin + Docetaxel Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenously inject with 5-FU (400 mg/m2) | Procedure | 5-FU (400 mg/m2) will be injected IV bolus before operation. After CRS, the patients will be treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients will be collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment will be sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC will be analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group will be compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in RNA in Tumor Tissues Before and After HIPEC | Main index parameters: information on the amount of differentially expressed genes and the magnitude of change between the cisplatin group and the cisplatin+ docetaxel group. The amount of differentially expressed genes is expressed as mean ± standard deviation and statistically analyzed by t-test or rank-sum test, and the comparison between groups is performed by unpaired t-test. Differences are considered statistically significant when P< 0.05. Based on the statistical results, the efficacy of the two HIPEC regimens (cisplatin or cisplatin+ docetaxel) on PMP will be analyzed. Expected results and clinical interpretation: More changes in newly generated RNA in the tumor tissue indicate a greater impact of HIPEC on the transcriptome of the tumor cells, possibly indicating better efficacy. | From the initiation of Cytoreductive Surgery (CRS) to the completion of Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CRS takes 4-8 hours, HIPEC takes 1 hour. Pre and post-HIPEC tumor tissues were collected for RNA-sequencing. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Transcriptomic Changes Detected by Flura-seq vs. Bulk RNA-seq | This secondary outcome quantifies and compares differentially expressed genes (DEGs) identified via Flura-seq (spatial transcriptomics) and bulk RNA-seq methodologies across all samples collected before and after hyperthermic intraperitoneal chemotherapy (HIPEC). | From the initiation of Cytoreductive Surgery (CRS) to the completion of Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CRS takes 4-8 hours, HIPEC takes 1 hour. Pre and post-HIPEC tumor tissues were collected for RNA-sequencing. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yan Li, PhD | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28825433 | Background | Wang 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. | |
| 27896510 | Background | Mehta 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. |
Not provided
Not provided
Sequencing raw data
From 2025 to 2028
For information sharing, contact the PI to access the IPD
Not provided
After providing informed consent, 36 enrolled participants entered a screening phase to confirm eligibility based on predefined inclusion/exclusion criteria. All 36 participants successfully completed screening and proceeded to randomization. No participants were excluded or withdrew during this phase. Using a randomization table provided by the Beijing Tsinghua Changgung Hospital Clinical Data Management Center, the 36 participants were randomly assigned to two groups (18 participants per group
Recruitment was conducted at a single-center hospital (Beijing Tsinghua Changgung Hospital, Department of Peritoneal Oncology) from February 17, 2025, to August 6, 2025. Potential participants were identified through outpatient clinics and physician referrals. All screened individuals underwent preliminary eligibility assessment based on the study's inclusion and exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental : Cisplatin Group | 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2025 |
Not provided
This study is a single-center, double-arm, open-label exploratory clinical study. The patients will be randomly divided into cisplatin group and cisplatin + docetaxel group, each group contains 18 patients. 5-FU (400 mg/m2) will be injected IV bolus before operation. After CRS, the patients will be treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients will be collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment will be sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC will be analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group will be compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor. It lays a foundation for optimizing HIPEC regimen and judging new therapeutic targets.
Not provided
Not provided
Not provided
Not provided
|
| 30912515 | Background | Basnet 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. |
| 7362446 | Background | Fernandez RN, Daly JM. Pseudomyxoma peritonei. Arch Surg. 1980 Apr;115(4):409-14. doi: 10.1001/archsurg.1980.01380040037006. |
| 22614976 | Background | Chua 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. |
| 9782010 | Background | Hinson FL, Ambrose NS. Pseudomyxoma peritonei. Br J Surg. 1998 Oct;85(10):1332-9. doi: 10.1046/j.1365-2168.1998.00882.x. |
| 26492181 | Background | Carr 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. |
| 27065718 | Background | Ramaswamy V. Pathology of Mucinous Appendiceal Tumors and Pseudomyxoma Peritonei. Indian J Surg Oncol. 2016 Jun;7(2):258-67. doi: 10.1007/s13193-016-0516-2. Epub 2016 Mar 19. |
| 18590843 | Background | Smeenk RM, Bruin SC, van Velthuysen ML, Verwaal VJ. Pseudomyxoma peritonei. Curr Probl Surg. 2008 Aug;45(8):527-75. doi: 10.1067/j.cpsurg.2008.04.003. No abstract available. |
| FG001 | Active Comparator : Cisplatin + Docetaxel Group | 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor. |
| COMPLETED |
|
| NOT COMPLETED |
|
All 36 participants who were randomized and assigned to the two study arms (18 per group) are included in the baseline analysis. There was no discrepancy between the number of participants enrolled, randomized, and included in the baseline characteristics analysis. No participants were excluded post-randomization prior to baseline assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental : Cisplatin Group | 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor. |
| BG001 | Active Comparator : Cisplatin + Docetaxel Group | 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age 18-75 years old, regardless of gender and race | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Histological characteristics of 36 PMP patients treated with CRS+HIPEC | The four level classification (Acellular mucus, low-grade mucinous carcinoma peritoneum, high-grade mucinous carcinoma peritoneum, high-grade mucinous carcinoma peritoneum with signet ring cells) is based on the 2016 Peritoneal Surface Oncology Group International (PSOGI) consensus classification standard. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in RNA in Tumor Tissues Before and After HIPEC | Main index parameters: information on the amount of differentially expressed genes and the magnitude of change between the cisplatin group and the cisplatin+ docetaxel group. The amount of differentially expressed genes is expressed as mean ± standard deviation and statistically analyzed by t-test or rank-sum test, and the comparison between groups is performed by unpaired t-test. Differences are considered statistically significant when P< 0.05. Based on the statistical results, the efficacy of the two HIPEC regimens (cisplatin or cisplatin+ docetaxel) on PMP will be analyzed. Expected results and clinical interpretation: More changes in newly generated RNA in the tumor tissue indicate a greater impact of HIPEC on the transcriptome of the tumor cells, possibly indicating better efficacy. | Posted | Mean | Standard Deviation | Numbers of changed RNA | From the initiation of Cytoreductive Surgery (CRS) to the completion of Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CRS takes 4-8 hours, HIPEC takes 1 hour. Pre and post-HIPEC tumor tissues were collected for RNA-sequencing. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Comparison of Transcriptomic Changes Detected by Flura-seq vs. Bulk RNA-seq | This secondary outcome quantifies and compares differentially expressed genes (DEGs) identified via Flura-seq (spatial transcriptomics) and bulk RNA-seq methodologies across all samples collected before and after hyperthermic intraperitoneal chemotherapy (HIPEC). | Posted | Mean | Standard Deviation | Numbers of changed RNA | From the initiation of Cytoreductive Surgery (CRS) to the completion of Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CRS takes 4-8 hours, HIPEC takes 1 hour. Pre and post-HIPEC tumor tissues were collected for RNA-sequencing. |
|
|
From the end of CRS+HIPEC treatment to 30 days after surgery.
The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin Group | 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. | 0 | 18 | 0 | 18 | 0 | 0 |
| EG001 | Cisplatin + Docetaxel Group | 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. | 0 | 18 | 0 | 18 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous Thromboembolism Occurrence (time, symptoms and signs, ultrasound/CTA, measures, prognosis) | General disorders | Systematic Assessment | Details on time, symptoms, diagnostic imaging (ultrasound/CTA), treatment measures and prognosis. May be related to surgical intervention. Assessed through clinical records. |
| |
| Symptomatic Deep - Vein Thrombosis | General disorders | Systematic Assessment | Detected by clinical symptoms, signs and confirmed via ultrasound. Associated with post - operative or high - risk conditions. |
| |
| Pulmonary Embolism | Vascular disorders | Systematic Assessment | Diagnosed by CTA. Symptoms include dyspnea, chest pain. Can be life - threatening and related to VTE risk factors. |
| |
| Post - operative Gastrointestinal Fistula | Gastrointestinal disorders | Systematic Assessment | Identified through clinical examination and imaging techniques. |
| |
| Bone Marrow Suppression | Blood and lymphatic system disorders | Systematic Assessment | Assessed by blood cell counts (WBC, RBC, platelets). Graded according to severity. |
| |
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment | Symptoms are abdominal pain, vomiting, constipation. Diagnosed by clinical presentation and imaging. |
| |
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment | Diagnosed by urine tests and symptoms like frequency, urgency. Treated with antibiotics. |
| |
| Urinary Fistula | Renal and urinary disorders | Systematic Assessment | Detected by abnormal urine leakage, imaging is used for further evaluation. |
| |
| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment | Assessed by serum creatinine, BUN, eGFR. Severe cases may need dialysis. |
| |
| Massive Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment | Defined by significant blood loss and low hemoglobin levels. May require blood transfusion. |
| |
| Respiratory system (pneumonia, pleural effusion, pneumothorax) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Diagnosed by clinical symptoms and chest imaging. |
| |
| Circulatory system (arrhythmia, hypotension, ischemic cardiomyopathy, pulmonary edema) | Cardiac disorders | Systematic Assessment | Assessed by ECG, blood pressure monitoring, imaging. May be related to anesthesia or post - op state. |
| |
| Nervous system (stroke, neurological paralysis) | Nervous system disorders | Systematic Assessment | Diagnosed by neurological examination and brain imaging. |
| |
| Intra - abdominal Infection | Infections and infestations | Systematic Assessment | Detected by abdominal pain, fever, and imaging showing fluid collection. |
| |
| Incision dehiscence, infection | Skin and subcutaneous tissue disorders | Systematic Assessment | Visually inspected for dehiscence, swabbed for infection testing. |
| |
| Venous catheterization (septicemia, embolism, pneumothorax) | Injury, poisoning and procedural complications | Systematic Assessment | Detected by clinical symptoms and imaging. |
|
Not provided
The case number is limited as PMP is a rare disease. Conducting future multicenter studies could potentially facilitate the accumulation of a larger sample size, thereby enabling more robust analyses.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yan Li, Director of the Department of Peritoneal Oncology | Tsinghua Changgung Hospital | +86 18612709123 | lya03816@btch.edu.cn |
| Dec 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011553 | Pseudomyxoma Peritonei |
| ID | Term |
|---|---|
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| low-grade mucinous carcinoma peritoneum |
|
| high-grade mucinous carcinoma peritoneum |
|
| high-grade mucinous carcinoma peritoneum with sign |
|
| Participants |
|
|