Colorectal Cancer Metastatic Clinical Trial
Official title:
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Verified date | August 2020 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In order to more accurately discover the cause of drug resistance in tumor treatment, and to
provide a new basis for precise treatment.
Therefore, based on the umbrella theory of precision medicine, we carried out this
single-center, prospective, and observational study to include patients with liver metastases
from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we
established a basis for colorectal cancer liver Transfer the multi-omics data of the sample,
describe the reason for the resistance of the first-line treatment, and search for new
therapeutic targets.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - ECOG score 0-2 points - Pathologically diagnosed patients with colorectal cancer - Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard) - The lesion is available - First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment - Informed consent Exclusion Criteria: - With brain metastases - History of other malignancies - Pregnancy or breastfeeding - Have received other drug clinical studies within 30 days before the start of this study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete remission (CR) and partial remission (PR) cases | 1 year | |
Secondary | progression-free survival | Refers to the date from initial diagnosis to tumor progression | 1 year | |
Secondary | Overall survival | Refers to the date from initial diagnosis to last follow-up or death date | 3 years |
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