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

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ClinicalTrials.gov Identifier: NCT05661110
Recruitment Status : Not yet recruiting
First Posted : December 22, 2022
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment
Gastric Cancer Other: Observational

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Biomarker Analysis for Hyperthermic Intraperitoneal Chemotherapy(HIPEC) Combined PD1/PDL1 Inhibitor Treatment in Patients of Advanced Gastric Cancer With Peritoneal Metastasis
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Relationship between the status, numerical changes of ctDNA during HIPEC combined with PD1/PDL1 inhibitor conversion therapy and postoperative R0 resection rate. [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Genomic changes of ctDNA and see if they are predictive of ORR. [ Time Frame: 3 months ]
    Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR))/total number of subjects ×100%. Measurable lesion according to the Response Evaluation Criteria In Solid Tumours(RECISTv1.1). To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during treatment.

  2. Genomic changes of ctDNA and see if they are predictive of overall survival time. [ Time Frame: 2 years ]
    Overall survival time(OS) refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during and after treatment.

  3. Genomic changes of ctDNA and see if they are predictive of event-Free Survival. [ Time Frame: 2 years ]
    Event-Free Survival(EFS): Defined as the interval between the first conversion therapy and the first recorded related events, including preoperative disease progression, postoperative disease recurrence, and death from any cause. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during and after treatment.

  4. Genomic changes of ctDNA and see if they are predictive of relapse-Free Survival. [ Time Frame: 2 years ]
    Relapse-Free Survival(RFS): Defined as postoperative the first recorded postoperative recurrence of disease or death from any cause. To dynamically evaluate the ctDNA profiles by next-generation sequencing and illustrate the genomic changes of ctDNA at baseline, during and after treatment.


Other Outcome Measures:
  1. Genetic and transcriptional profiling results. [ Time Frame: From baseline (prior to initiation of conversion therapy) ]
    Mutation and transcriptomic information will be recorded by NGS using AmoyDx® Master Panel, which contains 559 genes for DNA mutation detection and 1813 genes for RNA expression and fusion detection.


Biospecimen Retention:   Samples With DNA
Blood and residual tissue from surgery or tumor biopsy will be collected.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Advanced gastric adenocarcinoma confirmed by histology with peritoneal metastasis
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05661110


Contacts
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Contact: Ziying Lei, Doctor (086)020-66673666 ext 3772 leiziyinggz@126.com
Contact: Shuzhong Cui, Doctor 0086-138-0251-3800 cuishuzhong@gzhmu.edu.cn

Sponsors and Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Investigators
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Principal Investigator: Shuzhong Cui, Doctor Affiliated Cancer Hospital & Institute of Guangzhou Medical University
More Information
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Publications:

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Responsible Party: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT05661110    
Other Study ID Numbers: HIPEC-11
First Posted: December 22, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Affiliated Cancer Hospital & Institute of Guangzhou Medical University:
Biomarker
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases