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

Recruiting

• Conditions: Advanced or Late Stage Gastrointestinal Cancer
• Interventions: Device: EV-array detection

• Registration Number: NCT05427227
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Status Verified: 2022-07
• Study Start: 2022-07-01
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastrointestinal cancer (GI) patients receiving immunotherapy	EV-array detection	-
GI patients receiving anti-HER2 therapy	EV-array detection	-
GI patients receiving anti-CLDN18.2 therapy	EV-array detection	-

Primary Outcome Measures

Name	Time	Method
Tumor associated proteins expression level of exosomes	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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China