RadImm02: Clinical Research for the Consistency Analysis of PD-L1 in Lung Cancer Tissue and Plasma Exosome Before and After Radiotherapy

• Sponsor: Xinqiao Hospital of Chongqing (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02869685
• Collaborator: (none)
• Enrollment: 60
• Arm: 1

Study Details

Study Description

Brief Summary

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 tissues and pExo before and after radiotherapy.We 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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Radiation: radiotherapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Research for the Consistency Analysis of PD-L1 in Lung Cancer Tissue and Plasma Exosome Before and After Radiotherapy
• Study Start Date: Oct 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: a prospective, open,phase I clinical study We 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

Outcome Measures

Primary Outcome Measures

1. The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA expression in pExo before radiotherapy. [up to two and a half years]

2. The match rate of PD-L1 protein expression in tumor tissue and PD-L1 mRNA expression in pExo after radiotherapy. [up to two and a half years]

3. The best radiotherapy-division which can make PD-L1 express more. [up to two and a half years]

4. The best timing of radiotherapy which can make PD-L1 express more. [up to two and a half years]

Secondary Outcome Measures

1. Correlation between PD-L1 expression through radiation-induced and the ORR. [up to two and a half years]

2. Correlation between PD-L1 expression through radiation-induced and the radiation pneumonitis. [up to two and a half years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xinqiao Hospital of Chongqing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianguo Sun, Deputy Director, Xinqiao Hospital of Chongqing
• ClinicalTrials.gov Identifier: NCT02869685
• Other Study ID Numbers: XQonc-003
• First Posted: Aug 17, 2016
• Last Update Posted: Sep 1, 2016
• Last Verified: Aug 1, 2016

Study Results

No Results Posted as of Sep 1, 2016