Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

chengzhi zhou, PHD

Chengzhi Zhou, MD

Immunotherapy for PD-L1 positive patients is still ineffective in some patients，which may be related to the complex immune microenvironment.In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.

There are still some patients with PD-L1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks.

Recently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. Infiltration abundance of specific killer T cells; 2. PD-L1 expression dependent on IFN - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. Activation and clearance of various inhibitory T cells.

Although the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of TIL cells needs further refinement, and different types of TIL infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers It is not easy for different pathologists to reach an agreement on the results of reading and interpretation. Thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. In conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment.

In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.

Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC

Correlation between specific gene mutation and immune microenvironment

Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancer

Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients

Correlation of OS with specific gene mutation in immunotherapy of lung cancer

Correlation between immune microenvironment and OS in immunotherapy lung cancer patients

GeneCast Biotechnology Co., Ltd.

Guangzhou Institute of Respiratory Disease

PHD,Chief Physician

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

Julia T. Lewandowski

Jennifer Zhang, MD

This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.

Tissue from breast tumors removed as standard of care treatment for breast cancer.

Role of the Immune Environment in Response to Therapy in Breast Cancer

Individual participant data will not be shared with other researchers.

This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.

We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival.

Abramson Cancer Center at Penn Medicine

Assistant Professor of Surgery

Digestive System Diseases

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Immunologic Factors

Patients with locally advanced non-small cell lung cancer and locally advanced thoracic esophageal squamous cell carcinoma who met the entry and discharge criteria will be enrolled. After detecting the functional subsets of peripheral CD8-positive T cells, the group was randomly stratified 1:1, respectively. Group A received immunotherapy 24 hours after chemotherapy, and group B received chemotherapy 24 hours after immunotherapy.

Anti-PD-1 antibody, 240 mg, IV infusion for 30min (not less than 20min and not more than 60min), d1, every 3 weeks for total 2 cycles. Stratified regimen: group A, 24 hours after the end of chemotherapy; Group B will be given immunotherapy on the first day of each cycle.

Paclitaxel, 135 mg/m2, IV, d1, q3w, for total 2 cycles. Carboplatin, AUC=5 (according to Calvert formula), IV, d1, every 3 weeks for a total of 2 cycles. Stratified regimen: group A, chemotherapy will be given on day 1 of each cycle; Group B will be given chemotherapy drugs 24 hours after the end of immunotherapy.

Anti-PD-1 antibody combined with Paclitaxel and carboplatin.

After the completion of neoadjuvant immunochemotherapy, patients will be tested again for the functional subsets of peripheral CD8 positive T cells. Alternative treatments will be sought for inoperable patients. For patients who are operable will receive minimally invasive or open surgery was performed 1 month after completion of neoadjuvant chemotherapy immunotherapy, and the functional subsets of peripheral CD8 positive T cells were detected again after surgery.

Surgical treatment stage

Qiang Fang, PH.D

Qiang Fang

Chest malignant solid tumor (mainly lung and esophageal cancer) is a common malignant tumor that seriously threatens the health of residents in China. Its morbidity and mortality rank first, sixth, first, and fourth among all malignant tumors respectively. The treatment effect is not satisfactory, and the overall 5-year survival rate after surgery alone is about 20%-35%. Recent studies have shown that neoadjuvant therapy combined with surgery in the treatment of locally advanced esophageal cancer and lung cancer can significantly improve the efficacy compared with surgery alone. The results of multiple international and multi-center neoadjuvant immunotherapy showed that this new model of combined immunoadjuvant immunotherapy brought a breakthrough point for the treatment of malignant solid tumors of the chest. However, its safety and target benefit groups are still the biggest problems, and there is a large room for improvement. To develop the optimal treatment strategy, it is necessary to further clarify the immunomodulatory mechanisms of neoadjuvant CTIO, explore and develop new evaluation methods and prognostic biomarkers for the selection of targeted benefit patients, and the evaluation of efficacy. This is a key scientific issue in the current neoadjuvant CTIO treatment mode for thoracic malignant solid tumors, mainly lung and esophageal squamous cell carcinoma, which urgently needs to solve its safety and select the benefit population.

As a major participant in cellular immunity, CD8-positive T cells are considered to be the main anti-tumor immune effector cells. In addition to producing specific immune responses to viruses and other infections, their functional subsets are closely related to the occurrence and development of major human diseases. Therefore, we have reason to believe that the combination of dynamic monitoring of host immune background and traditional clinical evaluation can effectively clarify the immune background of patients with lung cancer and esophageal squamous cell carcinoma, and provide new ideas and methods for the selection of appropriate immunotherapy regimen and prognosis evaluation. However, the research in this field is still in its infancy.

This study is a prospective, single-arm, open cohort study (randomly stratified within the group).

Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumors of the Chest.

The Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumor of the Chest.

Objective Response Rate is defined as complete response (CR) + partial response (PR), from the beginning of regimental therapy to the end of neoadjuvant therapy, the efficacy of baseline target lesions was assessed by RECIST 1.1 criteria.

Pathological complete response is defined as 0% survival of tumor cells in surgically resected tumor samples after neoadjuvant therapy, as assessed by tumor regression grade.

Assess all adverse events according to the NCI Common Terminology Criteria for (NCI-CTCAE) v 4.0.3.

Progress Free Survival is defined as included the development of new metastases, or local progression of metastases or primary lesions that underwent surgical resection and will be assessed according to RESIST 1.1 criteria.

Sichuan Cancer Hospital and Research Institute

Principal Investigator, Clinical Professor.

Symptoms and General Pathology

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

T1 tumor with positive lymph node,N1/N2/N3

no intervention

Luminal type A breast cancer is a type with good clinical prognosis, and the proportion of lymph node metastasis is low, but a small number of patients have more lymph node metastasis when the primary tumor is very small, and the survival is poor, suggesting that this part of Luminal A breast cancer has the different expression of some genes from that of general Luminal A breast cancer, which affects tumor invasion and participates in the occurrence of tumor metastasis. But the mechanism is not clear, especially in the current tumor microenvironment and immune related mechanisms.We want to investigated the relationship of the transcriptional tumor immune microenvironment with early lymph node metastasis among Luminal A type breast cancer.

Tumor Immune Mechanism of Axillary Lymph Node Metastasis in Early Luminal Type A Breast Cancer

The Different Transcriptional Characterization Of The Tumor Immune Microenvironment of Luminal A Breast Cancer With Different Lymph Node Metastasas Status

the relationship of the transcriptional tumor immune microenvironment with lymph node metastases in Luminal A breast tumor;Differences in RNA copy numbers of different genes （using IO Panel） between the two groups of patients

Peking University People's Hospital

Adenocarcinoma

Patient under standard chemotherapy in localized and resectable gastric and gastroesophageal junctional adenocarcinomas

Clélia COUTZAC, MD

This trial is a prospective, monocentric, non-therapeutic, interventional cohort study aiming to decipher the immune TME through standard neoadjuvant CT in resectable G/GEJ adenocarcinomas. This study will also longitudinally monitor MRD during neoadjuvant and adjuvant therapy.

Tumor samples to be collected include:

1. Mandatory archival FFPE tumor block from initial diagnosis biopsy.
2. Mandatory fresh tumor samples performed before neoadjuvant CT and collected during gastroscopy.
3. Mandatory FFPE tumor samples from surgery specimen and lymph nodes collected during surgery.
4. Optional FFPE tumor block from biopsy or surgery in case of relapse.

Blood samples to be collected include:

1. At D1 pre-dose of neoadjuvant CT treatment
2. End of neoadjuvant treatment i.e. within at 1 month after the last neoadjuvant treatment
3. At surgery (within 2 days before or after surgery)
4. At M3, M6, M9, M12, M15, M19, M21, M24, M30, M36

GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas

Spatial, spectral cytometry, and transcriptomic analyses

Centre Leon Berard

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Cancer tissue specimens can be collected postoperatively following neoadjuvant chemotherapy.

Cancer tissue specimens can be directly collected postoperatively

Identification of rare cell populations, the characterization of cell types and subtypes, and the discovery of novel cell states.

Single-cell Sequencing Analysis

Yu Pan, M.D.

Yu Pan, M.D

Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group.

tumor tissue, paracancerous tissue, blood, and lymphonodu

Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients

There is no plan to make individual participant data (IPD) available to other researchers

Using single-cell sequencing technology, in-depth analysis of surgical samples from resectable/borderline resectable pancreatic cancer patients is conducted to investigate the composition and interactions of the tumor microenvironment in pancreatic cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC	NCT04405661	NSCLC		18 Years - 70 Years	Guangzhou Institute of Respiratory Disease
Role of the Immune Environment in Response to Therapy in Breast Cancer	NCT05396612	Breast Cancer ER Positive Bre... HER2-negative B... TNBC - Triple-N...	Collection of p...	18 Years -	Abramson Cancer Center at Penn Medicine
Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumors of the Chest.	NCT05044728	Non-small Cell ... Esophageal Squa...	Anti-PD-1 antib... Surgical treatm...	18 Years - 72 Years	Sichuan Cancer Hospital and Research Institute
Tumor Immune Mechanism of Axillary Lymph Node Metastasis in Early Luminal Type A Breast Cancer	NCT04322331	Immune Microenv... Luminal A Lymph Node Meta...	no intervention	-	Peking University People's Hospital
GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)	NCT05644431	GastroEsophagea...		18 Years -	Centre Leon Berard
Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients	NCT06310902	Pancreatic Neop...	Single-cell Seq...	18 Years - 75 Years	Fujian Medical University Union Hospital

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