Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

Immunotherapy Clinical Trial

Official title:

Prospectively Predict the Efficacy of Precise Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334849
• Other study ID #: irBiomarker
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC

Description:

The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific tumor burden marker and this novel biomarker showed promising efficiency in monitoring disease progression during treatment.

Hence in this stuty, the investigator plan to recruit a prospective cohort to support the conclusions, and provide biomarkers to realize predicting and monitoring immunotherapeutic outcomes of GC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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 Carcinoma
• Immunotherapy
• Stomach Neoplasms

Intervention

Device:
• Circulating exosomal lncRNA-GC1 detection
Collect peripheral blood sample of 80 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect circulating exosomal lncRNA-GC1. Tumor response evaluation will be performed after two cycles of immunotherapy 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	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of circulating exosomal lncRNA-GC1	Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.	Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline
Primary	Levels of circulating exosomal lncRNA-GC1	Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.	Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year
Secondary	Survival outcomes of circulating exosomal lncRNA-GC1	Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR.	up to 3 years