NSCLCRadImm02NCT02869685
Consistency Analysis of PD-L1s in Advanced NSCLC Tissues and in Plasma Exosomes Before and After Radiotherapy
A study testing radiotherapy in people with NSCLC, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 40037
About this study
Official 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
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.
Read the 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.
- Conditions
- NSCLC
- Being tested
- radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| a prospective, open,phase I clinical study | Other | 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. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: up to two and a half years
Secondary outcomes (2)
Correlation between PD-L1 expression through radiation-induced and the ORR.
Correlation between PD-L1 expression through radiation-induced and the ORR.
Measured: 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.
Measured: up to two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start1 Jul 2017
- Primary completion30 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
- Investigators
- jianguo sun, Phd, Study director, Second Affiliated Hospital of Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869685
- Sponsor's protocol ID
- XQonc-003
- Acronym
- RadImm02
- Status last verified
- Feb 2024
- First submitted
- 2 Aug 2016
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02869685
- Acronym / sponsor ID
- RadImm02 / XQonc-003
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a prospective, open,phase I clinical study | Other | Radiation: radiotherapyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyradiotherapy | Radiation | a prospective, open,phase I clinical study |
Primary outcome
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
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
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.
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.
2 secondary outcomes
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 radiation pneumonitis.
Time frame: up to two and a half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jianguo sun, Phd study director
Second Affiliated Hospital of Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy in people with NSCLC, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.