Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases ((RT-ICI))
2026년 6월 9일 업데이트: Rongrong Zhou, Xiangya Hospital of Central South University
Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.
The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are:
- Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?
- What medical problems do participants have when receiving these treatments at different times?
- How does the timing of treatments affect the body's immune system?
Researchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety.
Participants already receiving radiation and immunotherapy as part of their regular medical care will:
- Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.
- Give a small blood sample during their routine blood draws.
- Have standard magnetic resonance imaging (MRI) scans of their brain.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
관찰
등록 (추정된)
등록
150
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Rongrong Zhou, MD, PHD
- 전화번호: +8613875898127
- 이메일: zhourr@csu.edu.cn
연구 연락처 백업
- 이름: Weihua Liao, MD, PHD
- 전화번호: +8613973126486
- 이메일: ouwenliao@163.com
연구 장소
-
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Hunan
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Changsha, Hunan, 중국
- Xiangya Hospital of Central South University
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연락하다:
- Rongrong Zhou, MD, PHD
- 전화번호: +8613875898127
- 이메일: zhourr@csu.edu.cn
-
연락하다:
- Weihua Liao, MD, PHD
- 전화번호: +8613973126486
- 이메일: ouwenliao@163.com
-
부수사관:
- Xianjing Chu, MD
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
The study population comprises adult patients (aged 18 years and older) histologically or cytologically diagnosed with non-small cell lung cancer (NSCLC) accompanied by brain metastases, confirmed via contrast-enhanced head MRI.
These patients are seeking treatment at Xiangya Hospital and are scheduled to receive a combination of radiotherapy and PD-1/PD-L1 immune checkpoint inhibitors according to their routine, real-world clinical care plans.
The cohort specifically represents a real-world NSCLC population with relatively good performance status (ECOG 0-2), intact local brain anatomy (no prior history of whole-brain radiotherapy, stereotactic radiosurgery, or brain surgery), and who are negative for actionable driver mutations or have experienced disease progression following prior targeted therapies.
설명
Inclusion Criteria:
- Age ≥ 18 years; no gender restriction;
- Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI;
- Scheduled to receive radiotherapy combined with a PD-1/PD-L1 inhibitor, in accordance with real-world clinical treatment plans;
- Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy;
- ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months;
- Voluntarily signs the informed consent form and agrees to cooperate with blood/imaging data collection and follow-up procedures.
Exclusion Criteria:
- History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery;
- Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency);
- Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents;
- Pregnant or lactating women;
- Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
1
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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Non-small cell lung cancer brain metastases
This cohort comprises adult patients (aged 18 years and older) with histologically or cytologically confirmed (NSCLC who have brain metastases confirmed by contrast-enhanced head MRI. Participants in this cohort are scheduled to receive standard-of-care radiotherapy combined with PD-1/PD-L1 immune checkpoint inhibitors based on real-world clinical treatment plans. Eligible participants must have an ECOG performance status of 0 to 2, an expected survival of at least 3 months, and be either driver-gene negative or have experienced disease progression following prior targeted therapies. The cohort strictly excludes patients who have a history of WBRT, SRS for brain metastases, or brain surgery. Additionally, individuals with contraindications to MRI (or intolerance to gadolinium contrast agents), active autoimmune diseases requiring systemic treatment or long-term high-dose immunosuppressants, and pregnant or lactating women are excluded. |
Participants in this observational study receive standard-of-care radiotherapy for brain metastases combined with PD-1/PD-L1 immune checkpoint inhibitors. The specific radiotherapy parameters (e.g., technique, target volume, and dose) and immunotherapy details (e.g., specific drug type, dosage, and administration schedule) are entirely determined by the treating physicians or multidisciplinary team (MDT) based on current clinical guidelines and real-world practice. This study does not assign, alter, or proactively intervene in any treatment plans. What distinguishes the exposure in this study is the specific tracking and categorization of the real-world timing interval and administration sequence between radiotherapy and immunotherapy (e.g., synchronous vs. asynchronous, radiation-first vs. immunotherapy-first), aiming to evaluate how these naturally occurring temporal variations impact clinical outcomes and immune status. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intracranial Progression-Free Survival (iPFS)
기간: Up to approximately 2 years (Assessed every 2-3 months in the first year, and every 3-6 months thereafter until disease progression or death).
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Defined as the time from study enrollment (or completion of baseline assessment) to the first documented intracranial disease progression according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria via blinded independent central review, or death from any cause.
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Up to approximately 2 years (Assessed every 2-3 months in the first year, and every 3-6 months thereafter until disease progression or death).
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intracranial Objective Response Rate (iORR)
기간: Up to approximately 2 years.
|
The proportion of patients achieving an intracranial Complete Response (CR) or Partial Response (PR) per RANO-BM criteria.
Responses must be confirmed by consecutive imaging assessments at least 4 weeks apart.
|
Up to approximately 2 years.
|
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Overall Survival (OS)
기간: Up to approximately 2 years.
|
Defined as the time from study enrollment to death from any cause.
|
Up to approximately 2 years.
|
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Duration of Response (DOR)
기간: Up to approximately 2 years.
|
For patients achieving confirmed CR or PR, defined as the time from the first documented objective response to the first documented disease progression or death from any cause.
|
Up to approximately 2 years.
|
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Best Overall Response (BOR)
기간: Up to approximately 2 years.
|
The best disease response recorded from the start of the study treatment until disease progression or recurrence.
|
Up to approximately 2 years.
|
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Intracranial Disease Control Rate (iDCR)
기간: At 24 weeks
|
The proportion of patients who achieve CR, PR, or Stable Disease (SD) maintained for at least a specified time period (e.g., 24 weeks).
|
At 24 weeks
|
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Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)
기간: From enrollment up to 1 years after the last dose of immunotherapy.
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Evaluated and tracked according to the NCI CTCAE v5.0 and specific irAE management guidelines to assess the safety of different treatment sequences.
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From enrollment up to 1 years after the last dose of immunotherapy.
|
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Incidence of Radiation Necrosis and Severe Brain Edema
기간: Up to approximately 2 years.
|
Dynamic monitoring and evaluation of the occurrence of radiation necrosis and Grade ≥3 radiation-induced brain edema, utilizing RANO-BM and related imaging criteria.
|
Up to approximately 2 years.
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parasagittal Dura (PSD) Volume
기간: Baseline and follow-up MRI assessments up to approximately 2 years.
|
Quantitative measurement of the parasagittal dura (PSD) volume derived from contrast-enhanced 7.0T MRI.
PSD volume will be calculated using standardized image segmentation and volumetric analysis procedures and reported in cubic millimeters (mm³).
|
Baseline and follow-up MRI assessments up to approximately 2 years.
|
|
Meningeal Lymphatic Drainage Rate
기간: Baseline and follow-up MRI assessments up to approximately 2 years.
|
Quantitative assessment of meningeal lymphatic drainage efficiency measured using contrast-enhanced 7.0T MRI.
Drainage rate will be calculated according to predefined imaging analysis protocols and expressed as a percentage or kinetic parameter reflecting lymphatic drainage function.
|
Baseline and follow-up MRI assessments up to approximately 2 years.
|
|
Meningeal Lymphatic Vessel Diameter
기간: Baseline and follow-up MRI assessments up to approximately 2 years.
|
Mean diameter of visualized meningeal lymphatic vessels measured on contrast-enhanced 7.0T MRI using standardized image analysis methods and reported in millimeters (mm).
|
Baseline and follow-up MRI assessments up to approximately 2 years.
|
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Deep Cervical Lymph Node (dCLN) Inflow Rate
기간: Baseline and follow-up MRI assessments up to approximately 2 years.
|
Quantitative assessment of contrast agent inflow into deep cervical lymph nodes measured using contrast-enhanced 7.0T MRI.
The inflow rate will be used as an indicator of meningeal lymphatic drainage function.
|
Baseline and follow-up MRI assessments up to approximately 2 years.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 6월 5일
기본 완료 (추정된)
기본 완료
2029년 5월 31일
연구 완료 (추정된)
연구 완료
2030년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 4일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 10일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026051108
- ZXQ2026B05 (기타 보조금/기금 번호: Central South University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
IPD will not be made publicly available on open-access platforms to safeguard patient privacy.
However, de-identified and aggregated datasets, or specific subsets of IPD underlying the published results, might be shared conditionally.
Such data will only be provided upon reasonable request from qualified academic researchers, subject to the approval of the Institutional Review Board (IRB) of Xiangya Hospital and the execution of a formal Data Use Agreement (DUA).
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .