Biomarker Analysis of HIPEC Combined With PD1/PDL1 Inhibitor for Gastric Cancer With Peritoneal Metastasis

NCT05661110 | Not Yet Recruiting

• 1 other identifier: HIPEC-11
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single-center, observational study, integrated biomarker analysis of HIPEC combined Programmed cell death 1 /Programmed cell death 1 ligand 1(PD1/PDL1)inhibitor in previously treated patients of advanced gastric cancer with peritoneal metastasis. Tests will be performed on tumor tissue and blood samples, and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment. This is an observational study, so participants will not receive cancer treatment, other than the treatment received as standard of care.

Conditions

Gastric Cancer

Keywords

Biomarker

Outcome Measures

Primary Outcomes (1)

• Relationship between the status, numerical changes of ctDNA during HIPEC combined with PD1/PDL1 inhibitor conversion therapy and postoperative R0 resection rate.

  R0 resection rate refers to the proportion of all patients with negative margins under the microscope of tumor specimens after surgery to the total number of participants. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during treatment.

  3 months

Secondary Outcomes (4)

• Genomic changes of ctDNA and see if they are predictive of ORR.

  3 months

• Genomic changes of ctDNA and see if they are predictive of overall survival time.

  2 years

• Genomic changes of ctDNA and see if they are predictive of event-Free Survival.

  2 years

• Genomic changes of ctDNA and see if they are predictive of relapse-Free Survival.

  2 years

Other Outcomes (1)

• Genetic and transcriptional profiling results.

  From baseline (prior to initiation of conversion therapy)

Study Arms (1)

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.

Other: Observational

Interventions

Observational OTHER

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.

Prospective Sample Collection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced gastric adenocarcinoma confirmed by histology with peritoneal metastasis

You may qualify if:

• Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
• Age 18-75 years, Male or Non-pregnant female
• Eastern Cooperative Oncology Group(ECOG): 0\~1；
• Negative for human epidermal growth factor receptor 2(HER-2) by immunocytochemistry or fluorescence in situ hybridization；
• The presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
• Patients had received HIPEC combined with PD1/PDL1 inhibitor conversion therapy.
• Signed the Informed Consent Form, and blood and tissue samples can be obtained;

You may not qualify if:

• Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Related Publications (3)

• 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.

  PMID: 31988276 BACKGROUND

• 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.

  PMID: 34606846 BACKGROUND

• 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.

  PMID: 33609722 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and residual tissue from surgery or tumor biopsy will be collected.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Shuzhong Cui, Doctor

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziying Lei, Doctor

CONTACT

(086)020-66673666; leiziyinggz@126.com

Shuzhong Cui, Doctor

CONTACT

0086-138-0251-3800; cuishuzhong@gzhmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 22, 2022
• Study Start: January 1, 2023
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share