Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients
연구 개요
상태
정황
상세 설명
This study aims to identify the metabolic pathways related to the tumor microenvironment in NSCLC patients and their role in the response to ICI.
To this end, the metabolic picture will be evaluated on tumor-associated fibroblasts and macrophages tumor-associated and tumor-infiltrating lymphocytes, obtained from tissue samples of two different cohorts of patients candidate to receive immune-checkpoint treatment inhibitors. Furthermore it will correlate metabolic alterations in tumor tissues and peripheral immune cells or in plasma proteins of NSCLC patients with clinical response to ICIs.
For this purpose, serum/plasma and peripheral blood mononuclear cells (PBMC) will be isolated from the peripheral blood of patients to carry out phenotypic, metabolic and transcriptional studies on cells peripheral immune system. Finally it will come explored the therapeutic modulation of metabolic signatures identified in ex vivo models, using organoids and cultures of organotypic tissue sections obtained from patients affected by NSCLC, subjected to curative surgical treatment and treatment naive.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lorenza Landi, Doctor
- 전화번호: +39 06 5266 5699
- 이메일: lorenza.landi@ifo.it
연구 장소
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Rome
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Rome, Rome, 이탈리아, 00144
- 모병
- IRCCS National Cancer institute
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연락하다:
- Lorenza Landi, Doctor
- 전화번호: +39 06 5266 5699
- 이메일: lorenza.landi@ifo.it
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age > 18 years
- Histological diagnosis of advanced stage NSCLC
- Histotype adenocarcinoma and squamous carcinoma
- ECOG PS <2
- Known PDL-1 stage
- Measurable disease
- Availability of tumor tissue
- No evidence of molecular drivers
- Written informed consent (to the study and data processing)
For the second cohort in addition to the precedents it is included
- Diagnosis of limited or locally advanced NSCLC deemed resectable
For the third cohort in addition to the precedents it is included
- patients candidates for surgery for non-small cell lung cancer
Exclusion Criteria:
- Contraindications to immunotherapy
- Unavailability of tumor tissue
- Histotype with neuroendocrine or mixed component
For the second cohort
- Contraindication to immunotherapy
- Histotype with neuroendocrine or mixed component
- Locally advanced disease candidate for concomitant chemo-radiotherapy treatment
For the third cohort
- previously treated patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Serum collection
Collection of sera/plasma from 400 patients, present in the Institute's Biobank.
These are cells peripheral blood mononuclear cells (PBMC) and 150 tumor-infiltrating lymphocytes, cells immune cells that infiltrate adjacent non-tumor tissue and autologous CAFs from patients admitted to the IRE Institute for curative surgery.
20% of these patients relapse and access treatment Oncology Unit to be treated with immunotherapy according to the guidelines.
This allows the availability on archive of tumor tissue, PBMC, CAF and TIL frozen at the time collected of the intervention who, at the time of progression, will begin treatment with ICIs according to clinical guidelines
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Neoadjuvant treatment
Tissue taken will be collected, as per clinical practice, to curative surgery and when available to diagnostic biopsy.
We plan to biobank in prospective manner: PBMC and plasma at the start of neoadjuvant treatment, the day before of surgery and during clinical follow-up with a pattern of every 3 months for at least 6 months of follow up and where possible up to 21 months.
Evaluation of the response will be carried out by analysis of the pathological response in surgical tissue according to conventional criteria.
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Tissue samples
Collection of fresh tissue samples from treatment-naïve patients undergoing surgery for NSCLC.
Which will be prospectively biobanked, particularly PBMC and day-ahead plasma of the surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall survival OS
기간: 24 months
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The application of spatial transcriptomic approaches will enable the discovery of specific cellular niches that may be responsible for mechanisms of sensitivity or resistance to ICI.
With the results you get, you will probably have a chance to locate it new and wonderful metabolic pathways capable of exerting their anti-tumor effect even in combination with ICIs.
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24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lorenza Landi, Doctor, IRCCS National Cancer institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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