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

Immunotherapy Clinical Trial

Official title:

A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi-omics Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993378
• Other study ID #: CGOG-EV-1001
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment.

Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Other previous malignancy within 5 year

• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study

• Pregnancy or lactation period

• Legal incapacity

Related Conditions & MeSH terms

• Advanced Gastric Adenocarcinoma
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Immunotherapy

Intervention

Device:
• EV-array
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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shen Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival significance of EV-Score	Analysis patients' survival with different EV-Score.	up to 3 years