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

Launched by PEKING UNIVERSITY · Jun 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for patients with advanced or late-stage gastrointestinal (GI) cancer. The researchers are looking at how well certain treatments, like anti-HER2 therapy and immunotherapy, work by analyzing tiny particles in the blood called exosomes. These particles can provide important information about how the cancer is responding to treatment. The goal is to better understand the effectiveness of these therapies and the ways they work in fighting GI cancer.

To participate in this trial, you need to be between 18 and 80 years old and have a confirmed diagnosis of unresectable (unable to be surgically removed) or metastatic GI cancer. You should also have had some treatment for your cancer at least six months prior and be able to measure the disease with standard criteria. Participants will need to meet specific health requirements, such as having a good overall health status and certain blood test results. If you join the trial, you will undergo regular assessments and monitoring to help the researchers gather important data about your treatment and health. This trial is currently recruiting participants, and everyone is welcome to apply, regardless of gender.

Gender

ALL

Eligibility 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