NCT03679039

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colorectal Cancer With Liver Metastases

Timeline

• Start date: 2018-09-20
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2018-09-20
• Last updated: 2018-09-20

Locations

1 site across 1 country: China