Status:
UNKNOWN
Prospectively Predict the Efficacy and Explore the Mechanism of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy
Lead Sponsor:
Peking University
Conditions:
Advanced or Late Stage Gastrointestinal Cancer
Eligibility:
All Genders
18-80 years
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 progressi...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05427227
Start Date
July 1 2022
End Date
July 1 2025
Last Update
July 13 2022
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142