Clinical trial NCT05427227: Prospectively Predict the Efficacy and Explore the Mechanism of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced or Late Stage Gastrointestinal Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Tumor associated proteins expression level of exosomes
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: