Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Liver Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bile Duct Cancer

Primary Liver Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Immune Checkpoint Inhibitors

Liver Extracts

observe the association of ctDNA with efficacy of treatment

Observation

Feng Shen, MD PhD

To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors

In the study, 300 advanced primery liver cancer patients who received immune checkpoint inhibitors at first-line setting (N=200) or second-line setting (N=100) will be recruited. By analyzing the ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of ICI treatment, the dynamic changes of bTMB, ctDNA and the composition of immune cells will be detected. Combined with the tumor markers AFP, DCP and CA19-9, a noninvasive multiparameter model will be developed.

whole blood (including plasma, white cells), tissue

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer

The time length from the date of randomization to any of the following events: disease progression or death from any cause.

The proportion of patients with complete response or partial response.

The time length from the date of randomization to the date of death.

The time length from the date of randomization to the date of treatment discontinuation.

Eastern Hepatobiliary Surgery Hospital

Geneplus-Beijing Co. Ltd.

Biliary Tract Neoplasms

Biliary Tract Diseases

Biliary Tract Cancer

Gemcitabine

Following a tumour biopsy for molecular profiling, chemo-naive patients with advanced biliary tract cancer will receive first-line gemcitabine-based chemotherapy or an investigational drug on a participating clinical trial.

Tumour whole genome sequencing, germline whole genome sequencing, tumour whole transcriptome sequencing

Tumour and germline molecular profiling

George Zogopoulos, MD, PhD

Jennifer Gardner

Adeline Cuggia, MSc

Yifan Wang, MD

Biliary tract cancer (BTC) accounts for \<1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.

Molecular Profiling of Advanced Biliary Tract Cancers

Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study (COMPASS-B-MUHC)

We have estimated that 30 patients will be required to reach the primary end point, which will be met if we demonstrate that tumor whole genome sequencing data is available at 8 weeks from the tumour biopsy for 80% of patients.

Number of patients that achieve stability of disease (cancer) by imaging (RECIST criteria) with first-line standard chemotherapy, consisting of gemcitabine backbone.

Progression free survival (PFS) defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with 1st line chemotherapy.

Overall survival (OS) defined as the interval between the date of registration and the date of death of patients treated with 1st line chemotherapy.

based on whole genome sequencing or RNA sequencing analyses.

based on the identification of an actionable mutation by whole genome sequencing or RNA sequencing.

Cancer Research Society

McGill University Health Centre/Research Institute of the McGill University Health Centre

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Adenocarcinoma of Lung

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Adenocarcinoma

Rongrong Chen, MD, PhD

Lianpeng Chang, MS

Shun Lu, MD

To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.

In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy

ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance

Resistant mutations will be identified from ctDNA or tissue mutations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer	NCT05292443	Primary Liver C... Hepatocellular ... Intrahepatic Ch... Combined Hepato...	Observation	18 Years - 80 Years	Geneplus-Beijing Co. Ltd.
Molecular Profiling of Advanced Biliary Tract Cancers	NCT04318834	Biliary Tract C...	Tumour and germ...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients	NCT04566432	Lung Neoplasms Lung Cancer, No... Adenocarcinoma ... Squamous Cell L...	Observation	18 Years -	Geneplus-Beijing Co. Ltd.

Spots Global Cancer Trial Database for whole transcriptome sequencing