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Prospectively Predict the Efficacy and Explore the Mechanism of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy

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ClinicalTrials.gov Identifier: NCT05427227
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Peking University

Brief Summary:
Dynamic multiomics detection of plasma derived exosomes to explore the efficacy and mechanism of anti-HER2, immunotherapy and anti-CLDN18.2 of gastrointestinal cancer.

Condition or disease Intervention/treatment
Advanced or Late Stage Gastrointestinal Cancer Device: EV-array detection

Detailed Description:
The investigators will recruit 500 advancer/late-stage gastrointestinal cancer patients.Blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. All samples will be processed by exosomes proteome detection to explore the efficacy and mechanism of anti-HER2, immunotherapy and anti-CLDN18.2 of gastrointestinal cancer.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy and Explore the Mechanism of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi- Omics Liquid Biopsy
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Gastrointestinal cancer (GI) patients receiving immunotherapy Device: EV-array detection
Collect peripheral blood sample of 500 GI patients at treatment baseline, every time point response till disease progression.Blood samples will be transferred to central lab to detect certain exosome proteins expression by EV-array.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastatic organ ,regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

GI patients receiving anti-HER2 therapy Device: EV-array detection
Collect peripheral blood sample of 500 GI patients at treatment baseline, every time point response till disease progression.Blood samples will be transferred to central lab to detect certain exosome proteins expression by EV-array.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastatic organ ,regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

GI patients receiving anti-CLDN18.2 therapy Device: EV-array detection
Collect peripheral blood sample of 500 GI patients at treatment baseline, every time point response till disease progression.Blood samples will be transferred to central lab to detect certain exosome proteins expression by EV-array.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastatic organ ,regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.




Primary Outcome Measures :
  1. Tumor associated proteins expression level of exosomes [ Time Frame: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    90 tumor associated proteins' expression level of plasma derived exosomes at treatment baseline, second time point response and disease progression time point will be recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients in this study were enrolled by the Department of gastrointestinal oncology, Peking University Cancer Hospital & Institute for conventional therapy or clinical trials
Criteria

Inclusion Criteria:

  • • Having signed informed consent

    • Age:18-80 years old
    • Histologically confirmed GI cancer
    • Unresectable recurrent or metastatic GI cancer
    • Previous neo-adjuvant or adjuvant treatment for GI cancer, if applicable, more than 6 months
    • Measurable disease according to the RECIST criteria
    • Karnofsky performance status ≥70
    • Life expectancy of ≥3 month
    • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
    • ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
    • Serum albumin level ≥3.0g/dL
    • Serum AKP < 2.5 times ULN
    • Serum creatinine <ULN, and CCr < 60ml/min
    • Bilirubin level < 1.5 ULN
    • WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

  • Previous systemic therapy for metastatic GI cancer

    • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
    • Allergic constitution or allergic history to protium biologic product or any investigating agents.
    • Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
    • Pregnancy or lactation period
    • Other previous malignancy within 5 year, except non-melanoma skin cancer
    • Legal incapacity

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): NCT05427227


Contacts
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Contact: Zhang Cheng, Ph.D 010-88196561 Qenya@163.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, Professor    010-88196561    Linshenpku@163.com   
Principal Investigator: Shen Lin, Professor         
Sub-Investigator: Zhang Cheng, Ph.D         
Sub-Investigator: Zhang Xiaotian, Professor         
Sponsors and Collaborators
Peking University
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Responsible Party: Peking University
ClinicalTrials.gov Identifier: NCT05427227    
Other Study ID Numbers: CGOG-EV-1002
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases