Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Herbal and Botanical

Oxaliplatin

Leucovorin

Fluorouracil

Capecitabine

Levoleucovorin

Folic Acid

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Cola

* Immunoscore low (I-Low; I0-1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.). Concomitantly, standardised physical excise (stair walking excise twice a week for 12 weeks), which will be monitored by an electronic sports device.
* Immunoscore intermediate-high (I-IntHi; I2-3): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.)
* Immunoscore high (I high; I4): no adjuvant treatment.

* TNM-based low-risk (pT1, pT2 or pT3 and pN1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.)
* TNM-based high-risk (pT4 and/or pN2): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.)

Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin

Immunoscore® assay

Increasing stair walking exercise twice a week over 12 weeks total.

Physical exercise

Johannes Laengle, MD, PhD

Michael Bergmann, MD

Michale Bergmann, MD

Jérôme Galon, PhD

The overall aim of this study is to prospectively validate the superiority of the Immunoscore as a decision guidance for adjuvant chemotherapy in stage III colon cancer patients, in comparison to the conventional TNM-based high- or low-risk classification.

Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

iMmunoscore Associated Decision GuIdance for adjuvaNt Chemotherapy and Physical Exercise in Stage III Colon Cancer (iMAGINE): a Prospective, Randomized, Open-label, Multicenter, Phase III Clinical Trial

Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause)

Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)

Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)

Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE).

Impact of Immunoscore stratification on quality of life assessed by the latest version of the European Organization for Research and Treatment of Cancer (EORCT) Quality of Life Group (QLG) questionnaires C30 and CR29.

Impact of Immunoscore stratification on treatment-related costs, assessed by cost-effectiveness analysis (CEA) according to the latest Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Sponsor-Investigator

Rectal Neoplasms

Rectal Diseases

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

6 cycles of mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) followed by long course chemoradiotherapy (50 Gy in 25 fractions) followed by surgery. Patients will receive sintilimab 3mg/kg every 2 weeks during chemoradiotherapy (2nd-6th cycle).

Sintilimab

Xiaobin Zheng, PhD,MD

Liang Kang, MD, PhD

Liang Kang, PhD,MD

Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.

This study investigates the safety, tolerability, and feasibility of sintilimab, an immunotherapy agent, in combination with nCRT for treatment of patients with intermediate/high Immunoscore locally advanced rectal cancer. Sintilimab is an anti-PD-1 inhibitor that works by enhancing the functional activity of the target immune cells to facilitate tumor regression and ultimately immune rejection.

Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer

Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial

Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging

Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis.

The correlation between the status of MRD and the tumor local recurrence and metastasis.

GeneCast Biotechnology Co., Ltd.

Yanhong Deng

Professor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.

A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.

Diagnostic Biopsy and Surgical Procedure

At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.

Intravoxel incoherent motion MRI (IVIM)

Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.

Dynamic Contrast Enhanced MRI (DCE-MRI)

RNA will be collected from biopsy and surgical tissue for gene expression analysis.

RNA gene expression analysis

Marka Crittenden, MD, PhD

This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.

Patients who enroll in the study will all undergo a biopsy as part of their standard of care evaluation. Biopsies samples will be obtained and sent to pathology for paraffin embedded blocks for diagnostic evaluation and for subsequent research. Patients will also have tissue stored in RNA later for subsequent microarray analysis.

Immunoscore in Rectal Cancer

A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy

This project is being done to contribute pathology samples and patient outcome data to a larger data set intended to validate an algorithm to predict patient outcome based on pathology data obtained at diagnosis. As part of this project, pre-existing samples will be used. There will be new slides made from the samples that will be stained to identify immune response. Pathology analysis and images of the slides will be provided (without patient identifiers) along with de-identified patient outcome data to a central coordinating center.

Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response.

Oregon Health and Science University

Providence Health & Services

Anti-Infective Agents

Formaldehyde

Secondary surgery is performed in patients with pejorative histopathologic feature(s) of the tumor.

Immunoscore Colon is an in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer.

The test uses immunohistochemistry, digital pathology techniques and a dedicated image analysis software to determine CD3+ and CD8 + cell densities in the tumor ant in the invasive margin of the tumor.

Immunoscore Colon Test

Touria El Aamri

Yvann Frigout

Franck PAGÈS, MD

Franck Pagès, MD

The overall aim of this study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

The frequency of stage T1 superficial colorectal cancer (CRC) is around 15% and its incidence increases. In France, T1 superficial CCR is mostly treated with endoscopic submucosal dissection (ESD), offering potentially curative, organ-preserving treatment. The presence of pejorative histological criteria (eg. poor differentiation, budding, lymphovascular invasion), detected in about 50% of the tumors, leads to a secondary colectomy or rectal resection with postoperative complications and significant digestive, urological, and sexual functional sequelae. Strikingly, secondary surgical resection is performed in excess in 70 to 80% of the cases, given that no tumor is evidence in the colon and draining lymph nodes. Organ preservation (no secondary surgery) could be offered to a larger number of patients if biomarkers could complete the histological evaluation to better predict metastatic extension to lymph nodes.

Our team showed that the type, density, and location of immune cells in CRC strongly correlated with patients' survival at all disease stages. Our team created an "Immunoscore" (IS) assay, based on CD3+ and cytotoxic CD8+ T-cell densities determined by digital pathology in the tumor and its invasive margin. The robustness and prognostic performance of IS was validated in CRC . Sub-analysis of T1 tumors was not possible (only 31 cases) and tumor specimens did not result from endoscopic resection.

The objective of the study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol could be shared for the purpose of a metaanalysis.

Impact of Immunoscore stratification on lymph node invasion rate in patients with secondary surgery

Impact of Immunoscore stratification combined to Histological risk factors on lymph node invasion rate

Assessment of Immunological features measured by RNA sequencing on tumor samples.

Assessment of molecular profile of the tumor by transcriptomic profile measured by RNAseq. CMS classification will be determined

National Cancer Institute, France

Ministry of Health, France

Assistance Publique - Hôpitaux de Paris

Immunoscore® is a tissue-based immune test that measures the host's immune response at the site of the tumor. It is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from resections of localized colon cancer. The test uses whole slide imaging and artificial intelligence algorithms for assessment of the type, density, and location of T cells in FFPE tumor sections to determine an individual Immunoscore® for each patient.

Camila M Moniz, PhD

Ingrid P Barbosa

Lucila S Rocha, MD

Mariana B Siqueira, MD

Paulo M Hoff, PhD

Fernando A Soares, PhD

The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively.

The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.

Colorectal cancer resection surgical biospecimen

Role of Immunoscore® in Stage II-III Colorectal Cancer

Impact of Immunoscore stratification on tumor recurrence at 2 years

Impact of Immunoscore stratification on DFS at 5 years

Impact of Immunoscore stratification on OS at 5 years

Impact of Immunoscore stratification on DFS in right and left tumors at 3 years

Impact of Immunoscore stratification on OS in right and left tumors at 3 years

Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions

Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status

Difference in monetary value due to Immuno Score stratification and chemotherapy indication

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer	NCT04488159	Colon Cancer St...	Capecitabine Oxaliplatin Fluorouracil Leucovorin Immunoscore® as... Physical exerci...	18 Years - 100 Years	Medical University of Vienna
Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer	NCT04488159	Colon Cancer St...	Capecitabine Oxaliplatin Fluorouracil Leucovorin Immunoscore® as... Physical exerci...	18 Years - 100 Years	Medical University of Vienna
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer	NCT05450029	Rectal Cancer	Sintilimab	18 Years - 75 Years	Sun Yat-sen University
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer	NCT05450029	Rectal Cancer	Sintilimab	18 Years - 75 Years	Sun Yat-sen University
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer	NCT05450029	Rectal Cancer	Sintilimab	18 Years - 75 Years	Sun Yat-sen University
Immunoscore in Rectal Cancer	NCT02017509	Cancer of the R... Neoplasms, Rect... Rectal Cancer Rectal Tumors Rectal Adenocar...	Diagnostic Biop... Intravoxel inco... Dynamic Contras... RNA gene expres...	18 Years -	Providence Health & Services
Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit	NCT06251726	Colorectal Canc...	Immunoscore Col...	18 Years -	Assistance Publique - Hôpitaux de Paris
Role of Immunoscore® in Stage II-III Colorectal Cancer	NCT05422547	Colon Adenocarc...	Immunoscore Col...	-	D'Or Institute for Research and Education

Spots Global Cancer Trial Database for immunoscore

Every month we try and update this database with for immunoscore cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for immunoscore

Every month we try and update this database with for immunoscore cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for immunoscore cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.