Predicting treatment outcomes for advanced gastrointestinal cancer using blood tests
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
This study is testing how well different treatments for advanced gastrointestinal cancer work by looking at blood samples from patients to see if they can predict treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05427227 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 500 patients with advanced or late-stage gastrointestinal cancer to investigate the efficacy and mechanisms of various treatments, including anti-HER2 therapy and immunotherapy. Blood and tumor tissue samples will be collected at baseline and throughout treatment to analyze exosomes through dynamic multiomics detection. The goal is to understand how these treatments work and their effectiveness in managing the disease over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with unresectable recurrent or metastatic gastrointestinal cancer who have measurable disease.
Not a fit: Patients who have received previous systemic therapy for metastatic gastrointestinal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with advanced gastrointestinal cancer.
How similar studies have performed: Other studies utilizing multi-omics approaches in cancer treatment have shown promise, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhang Cheng, Ph.D
- Email: Qenya@163.com
- Phone: 010-88196561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.