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Completed

NCT Number: NCT02869685

Consistency Analysis of PD-L1s in Advanced NSCLC Tissues and in Plasma Exosomes Before and After Radiotherapy

The detection of tissue PD-L1 immunohistochemistry in NSCLC has an important role in guiding for the treatment of immune detection point.Radiation therapy can enhance the effect of immunotherapy,but radiation dose and timing are waiting to be solved. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in advanced non-small cell cancer patients' cancer tissues and pExo before and after radiotherapy.The investigators have designed five kinds of radiation-division with bioequivalent doses, and detected the expression levels of PD-L1 in pExo after 24h, 48h of each stage of radiotherapy.PD-L1 mRNA levels in pExo detected at different time points,by using variance analysis of repeated measures design information.Probing the best timing and manner of radiotherapy division which can make PD-L1 express more,guiding clinical practice of radiotherapy combining with immunotherapy.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

About this study

Radiation therapy can enhance the effect of immunotherapy,but radiation dose and timing are waiting to be solved. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in advanced non-small cell cancer patients' cancer tissues and pExo before and after radiotherapy.The investigators have designed five kinds of radiation-division with bioequivalent doses, and detected the expression levels of PD-L1 in pExo after 24h, 48h of each stage of radiotherapy.PD-L1 mRNA levels in pExo detected at different time points,by using variance analysis of repeated measures design information.Probing the best timing and manner of radiotherapy division which can make PD-L1 express more,guiding clinical practice of radiotherapy combining with immunotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathological histology and/or cytology confirmed NSCLC;
  • Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC;
  • PS 0-2;
  • Expected survival > 3 months;
  • Age 18~75 years old;
  • The function of lung, liver, kidney, bone marrow was normal;
  • The patients had not received radiotherapy for previous primary tumor and metastases;
  • At least accept 2-4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy;
  • Wild-type EGFR;
  • Sensitive mutant EGFR, but refused to targeted therapy;
  • In line with the indications of radiotherapy and accept it;
  • Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion criteria

  • Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
  • Patients with other malignancies;
  • Patients with a history of autoimmune disease;
  • The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test);
  • In the activity of acute or chronic infectious diseases;
  • Patients with a clear history of drug allergy or allergic genus;
  • Patients with participating in other clinical trials at the same time;
  • Other cases that researchers believe that patients should not participate in the present trial.

Treatment and study plan

Radiotherapy

Radiation

radiotherapy

Primary outcomes

  1. The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA expression in pExo before radiotherapy.

    Time frame: up to two and a half years

    The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA

  2. The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA expression in pExo after radiotherapy.

    Time frame: up to two and a half years

    The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA

  3. The best radiotherapy-division which can make PD-L1 express more.

    Time frame: up to two and a half years

    The best radiotherapy-division which can make PD-L1 express more.

  4. The best timing of radiotherapy which can make PD-L1 express more.

    Time frame: up to two and a half years

    The best timing of radiotherapy which can make PD-L1 express more.

Secondary outcomes

  1. Correlation between PD-L1 expression through radiation-induced and the ORR.

    Time frame: up to two and a half years

    Correlation between PD-L1 expression through radiation-induced and the ORR.

  2. Correlation between PD-L1 expression through radiation-induced and the radiation pneumonitis.

    Time frame: up to two and a half years

    Correlation between PD-L1 expression through radiation-induced and the radiation pneumonitis.

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

Consistency Analysis of PD-L1s in Non-small Cell Lung Cancer Patients' Cancer Tissues and in Plasma Exosomes Before and After Radiotherapy:A Clinical Trial

Acronym: RadImm02

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2016
Registry last updated
Feb 23, 2024

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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