A Model for Predicting the Efficacy of Conversion Therapy for Patients With Colorectal Cancer Liver Metastases by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA

Colorectal Cancer With Liver Metastases Clinical Trial

Official title:

A Single-centre, Prospective, Cohort Trial of the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA for Establishing a Model for Predicting the Efficacy of Conversion Therapy for Patients With Unresectable Colorectal Cancer Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03679039
• Other study ID #: PROVE
• Status: Recruiting
• Start date: September 20, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: September 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, the investigators establish a model for predicting the efficacy of conversion therapy for the patients with unresectable liver metastases of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group.

Description:

Radical resection is the preferred treatment of colorectal cancer patients with liver metastasas which significantly reduce the survival. However, the majority of the patients cannot receive liver lesions resection resulting from the size, number and bad location. Conversion therapy can improve the resection rate of these patients. Unfortunately, the efficacy of conversion therapy is still poor in part of the patients. So, it is crucial to distinguish the beneficial ones from the others.

The aim of this single center study is to establish a model for predicting the efficacy of conversion therapy for the patients with unresectable liver metastases of colorectal cancer based on the detection of 5-hmC. Patients will be eligible for inclusion if they suffer with unresectable liver metastases of colorectal cancer and have not received any anti-tumor treatment. Eligible patients will be assigned to effective group (group A) and drug resistance group (group B) according to the evaluation results of multidisciplinary team after 4-8 cycles of conversion therapy about 2-4 months.

Then, 5-hmC in plasma cell-free DNA will be detected and compared between the two groups of patients (training group) to establish a model to predict the efficacy of convertion therapy of other individuals (validation group) who suffer with unresectable liver metastases of colorectal cancer receiving conversion therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven colorectal adenocarcinoma

• Liver metastases were observed by abdominal pelvic CT and / or MRI with/without other distant metastases

• The liver metastases assessed as unresectable lesions by multidisciplinary team

• No other malignancies in medical history

• Eastern cooperative oncology group score 0-2

• Informed consent

Exclusion Criteria:

• Patients received chemoradiotherapy or other anti-tumor therapy before being enrolled

• Patients and/or family members can not understand or accept this study

• Familial Adenomatous Polyposis, Lynch Syndrome, acute inflammatory bowel disease

• Pregnancy or lactation

• Unsuitable to take part in the clinical trial judged by doctors

Related Conditions & MeSH terms

• Colorectal Cancer With Liver Metastases
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of the model to predict the drug resistance	Sensitivity and specificity of the model in predicting the drug resistance in conversion therapy for colorectal cancer with unresectable liver metastases	4 months