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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced or Late Stage Gastrointestinal Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Zhang Cheng, Ph.D; Phone Number: 010-88196561; Email: Qenya@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer hospital
      • Sub-Investigator: Zhang Cheng, Ph.D
      • Sub-Investigator: Zhang Xiaotian, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor associated proteins expression level of exosomes	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.	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

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: CGOG-EV-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No