Biomarker Analysis of HIPEC Combined With PD1/PDL1 Inhibitor for Gastric Cancer With Peritoneal Metastasis
NCT ID: NCT05661110
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
46 participants
OBSERVATIONAL
2023-01-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective Sample Collection
Prospective sample collection from participants treated with HIPEC combined PD1/PDL1inhibitor at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University under standard of care treatment. Blood and tissue samples will be collected prior to initiation of conversion therapy. And thereafter at the four time points: before and after surgery(±7 days), before the start of the second cycle of adjuvant, tumour progression, blood sample will be collected too.
Observational
All patients will be treated with standard of conversion treatment with HIPEC combined PD1/PDL1 inhibitor. After obtaining written informed consent, participants will have serial blood, tumor tissue collection. The blood collection (10 ml) should coincide with routine clinical blood draw to minimize participant discomfort if possible. No additional procedures will be performed other than phlebotomy. Participants will remain on the study for as long as they are being followed or treated at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University. Participants can withdraw from the study at any time.
Interventions
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Observational
All patients will be treated with standard of conversion treatment with HIPEC combined PD1/PDL1 inhibitor. After obtaining written informed consent, participants will have serial blood, tumor tissue collection. The blood collection (10 ml) should coincide with routine clinical blood draw to minimize participant discomfort if possible. No additional procedures will be performed other than phlebotomy. Participants will remain on the study for as long as they are being followed or treated at Affiliated Cancer Hospital \& Institute of Guangzhou Medical University. Participants can withdraw from the study at any time.
Eligibility Criteria
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Inclusion Criteria
2. Age 18-75 years, Male or Non-pregnant female
3. Eastern Cooperative Oncology Group(ECOG): 0\~1；
4. Negative for human epidermal growth factor receptor 2(HER-2) by immunocytochemistry or fluorescence in situ hybridization；
5. The presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
6. Patients had received HIPEC combined with PD1/PDL1 inhibitor conversion therapy.
7. Signed the Informed Consent Form, and blood and tissue samples can be obtained;
Exclusion Criteria
2. Other patients who were considered unsuitable for inclusion by the researchers;
18 Years
75 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Shuzhong Cui, Doctor
Role: PRINCIPAL_INVESTIGATOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Central Contacts
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References
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Leal A, van Grieken NCT, Palsgrove DN, Phallen J, Medina JE, Hruban C, Broeckaert MAM, Anagnostou V, Adleff V, Bruhm DC, Canzoniero JV, Fiksel J, Nordsmark M, Warmerdam FARM, Verheul HMW, van Spronsen DJ, Beerepoot LV, Geenen MM, Portielje JEA, Jansen EPM, van Sandick J, Meershoek-Klein Kranenbarg E, van Laarhoven HWM, van der Peet DL, van de Velde CJH, Verheij M, Fijneman R, Scharpf RB, Meijer GA, Cats A, Velculescu VE. White blood cell and cell-free DNA analyses for detection of residual disease in gastric cancer. Nat Commun. 2020 Jan 27;11(1):525. doi: 10.1038/s41467-020-14310-3.
Wang D, Cabalag CS, Clemons NJ, DuBois RN. Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer. Gastroenterology. 2021 Dec;161(6):1813-1829. doi: 10.1053/j.gastro.2021.09.059. Epub 2021 Oct 2.
Smyth EC, Gambardella V, Cervantes A, Fleitas T. Checkpoint inhibitors for gastroesophageal cancers: dissecting heterogeneity to better understand their role in first-line and adjuvant therapy. Ann Oncol. 2021 May;32(5):590-599. doi: 10.1016/j.annonc.2021.02.004. Epub 2021 Feb 17.
Other Identifiers
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HIPEC-11
Identifier Type: -
Identifier Source: org_study_id