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Completed

NCT Number: NCT05334849

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

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

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Key information

Conditions

Advanced Gastric Carcinoma Immunotherapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circulating exosomal lncRNA-GC1 detection

Device

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.

Primary outcomes

  1. Levels of circulating exosomal lncRNA-GC1

    Time frame: Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline

    Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.

  2. Levels of circulating exosomal lncRNA-GC1

    Time frame: Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year

    Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.

Secondary outcomes

  1. Survival outcomes of circulating exosomal lncRNA-GC1

    Time frame: up to 3 years

    Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR.

Sponsors and collaborators

Lead sponsor

Lin Chen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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