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Trial Title:
Biomarker Analysis of HIPEC Combined With PD1/PDL1 Inhibitor for Gastric Cancer With Peritoneal Metastasis
NCT ID:
NCT05661110
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Biomarker
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational
Description:
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.
Arm group label:
Prospective Sample Collection
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.
Detailed description:
To analyze the correlation between genomic alterations, gene expression characteristics
and the efficacy of HIPEC combined with PD1/PDL1 inhibitor conversion therapy in patients
with peritoneal metastasis of gastric cancer. Circulating tumor DNA(ctDNA) in plasma
samples and DNA, RNA in tumor tissue sample were obtained over the course of HIPEC
combined PD1/PDL1 inhibitor conversion treatment will be assessed by high-intensity,
next-generation sequencing(NGS) to identify genomic alterations. The assay will performed
used AmoyDx® Master Panel(Amoy Diagnostics Co., Xiamen, China), which contains 559 genes
for DNA mutation detection and 1813 genes for RNA expression and fusion detection. Data
acquired will be analyzed to characterize the association between these genetic elements,
clinical response, and durability of responses. There will be prospective groups for the
study. Samples will be collected from patients in the prospective cohort who have been
treated with HIPEC combined PD1/PDL1 inhibitor at Affiliated Cancer Hospital & Institute
of Guangzhou Medical University under standard of conversion treatment.
Criteria for eligibility:
Study pop:
Advanced gastric adenocarcinoma confirmed by histology with peritoneal metastasis
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
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:
1. Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural,
brain, bone metastases, etc.);
2. Other patients who were considered unsuitable for inclusion by the researchers;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Start date:
January 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Source:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05661110
