임상 레이더 AI | ||
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임상시험 NCT06947694은(는) EGFR/ALK 돌연변이 없는 4기 비소세포 폐암 (NSCLC)에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases 2상 427 면역 요법 머신 러닝 바이오마커 기반
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06947694은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 EGFR/ALK 돌연변이 없는 4기 비소세포 폐암 (NSCLC)에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 7월 2일에 시작되어 427명의 참여자를 모집하고 있습니다. Xinqiao Hospital of Chongqing이(가) 진행하며, 2027년 12월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 22일에 갱신되었습니다.
간단한 개요
It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radioth...더 보기
공식 제목
A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
질환명
EGFR/ALK 돌연변이 없는 4기 비소세포 폐암 (NSCLC)기타 연구 식별자
- XQonc-024
NCT 번호
실제 연구 시작일
2025-07-02
최신 업데이트 게시
2025-07-22
예상 연구 완료일
2027-12-31
계획된 등록 인원
427
연구종류
중재연구
단계/상
2상
상태
모집중
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Group A | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy \* 3-10 fractions) for pulmonary lesions, lymph node lesions and visceral lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity is intolera...더 보기 |
실험적Group B | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolera...더 보기 |
실험적Group C | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and bone metastatic lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity become...더 보기 |
실험적Group D | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity becomes intolerab...더 보기 |
실험적Group E | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and bone metastatic lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes ...더 보기 |
실험적Group F | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerab...더 보기 |
실험적Group G | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerab...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The remission rate of abscopal lesions | The remission rate of abscopal lesions. Immunotherapy is administered within less than 1 week after the start of radiotherapy. The time point for determining the abscopal effect is set as ≤ 4 cycles of immunotherapy. The assessment is carried out in accordance with the RECIST 1.1 (Appendix 1) and iPERCIST criteria. | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
PFS | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | |
OS | up to 5 years | |
ORR | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | |
DOR | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | |
irAE | Adverse reactions related to immunotherapy | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years |
QoF | up to 2 years |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Patient must meet all of the following inclusion criteria to be enrolled in this study:
- Non-small cell lung cancer diagnosed initially through pathological histology.
- There are 3-6 metastatic lesions.
- No brain metastasis or the lesions are stable.
- Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
- ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
- Aged between 18 and 75 years old.
- Evaluated by PET-CT (including FDG and FMISO, not mandatory).
- No contraindications for immunotherapy and radiotherapy.
- The informed consent form has been signed.
Patients with any of the following criteria are not eligible for enrollment in this study:
- Those with severe dysfunction of vital organs (heart, liver, kidney).
- Those accompanied by other malignant tumors.
- Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
- Those with a history of mental illness.
- And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.
Xinqiao Hospital of Chongqing연구 책임자
Jianguo Sun, 책임연구자, prof, Xinqiao Hospital of Chongqing
연구 대표 연락처
연락처: Jianguo Sun, MD, 023-68774490, [email protected]
1 1개국에 임상시험 장소
Chongqing Municipality
the second affiliated hospital of Army medical university, Chongqing, Chongqing Municipality, 400037, China
jianguo Sun, Phd, 연락처, 023-68774490, [email protected]
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