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

NCT04993378 | Unknown

• 1 other identifier: CGOG-EV-1001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To vertify the function of EV-score on predicting \& monitoring immunotherapeutic outcomes of GC

Conditions

Advanced Gastric Adenocarcinoma; Immunotherapy

Keywords

plasma-based liquid biopsy protein biomarker; extracellular vesicles; protein biomarker

Outcome Measures

Primary Outcomes (1)

• EV-Score

  EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV

  EV-Score was detected, analysis and reported at the baseline of the treatment.

Secondary Outcomes (1)

• Survival significance of EV-Score

  up to 3 years

Study Arms (1)

GC patients receiving immunotherapy

Device: EV-array

Interventions

EV-array DEVICE

Collect peripheral blood sample of 40 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect EV-score by EV-array. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

GC patients receiving immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Having signed informed consent
• Age≥ 18 years old
• Histologically confirmed gastric adenocarcinoma
• Unresectable recurrent or metastatic disease
• Measurable disease according to the RECIST criteria
• Life expectancy of ≥3 month
• No prior chemotherapy of the study more than 4 weeks
• Immunotherapy regimens were included in the treatment

You may not qualify if:

• Other previous malignancy within 5 year
• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
• Pregnancy or lactation period
• Legal incapacity

Sponsors & Collaborators

• Shen Lin: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of GI oncology Affiliation: Peking University

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: November 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

CN (1)