Consistency Analysis of PD-L1s in Advanced NSCLC Tissues and in Plasma Exosomes Before and After Radiotherapy (RadImm02)

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

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Radiation: radiotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 40037
      • The Second Affiliated Hospital of Army Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: a prospective, open,phase I clinical study; 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.	Radiation: radiotherapy; radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA expression in pExo before radiotherapy.	The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA	up to two and a half years
The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA expression in pExo after radiotherapy.	The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA	up to two and a half years
The best radiotherapy-division which can make PD-L1 express more.	The best radiotherapy-division which can make PD-L1 express more.	up to two and a half years
The best timing of radiotherapy which can make PD-L1 express more.	The best timing of radiotherapy which can make PD-L1 express more.	up to two and a half years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between PD-L1 expression through radiation-induced and the ORR.	Correlation between PD-L1 expression through radiation-induced and the ORR.	up to two and a half years
Correlation between PD-L1 expression through radiation-induced and the radiation pneumonitis.	Correlation between PD-L1 expression through radiation-induced and the radiation pneumonitis.	up to two and a half years

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing
• Investigators: Study Director: jianguo sun, Phd, The Second Affiliated Hospital of Army Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimated): August 17, 2016

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: XQonc-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No