The Value of ctDNA on Chemotherapy Efficacy for mCRC

Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04555369

Enrollment

300

Registered

2020-09-18

Start date

2020-09-23

Completion date

2025-09-01

Last updated

2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor DNA

Brief summary

The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.

Interventions

GENETICct-DNA

The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function

Exclusion criteria

patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

Design outcomes

Primary

Measure	Time frame	Description
Response rate	2 months	the response rate predicted by ct-DNA

Secondary

Measure	Time frame
Progression free survival	2 months
Overall survival	2 months

Countries

China

Contacts

Primary ContactWeijian Guo, phD

iamchangjinjia@163.com8621-64175590

Backup ContactWeijian Guo