Clinical trial NCT05635630: Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention
Official title: Predictive Value of Circulating Tumor DNA (ctDNA) for no Evidence of Disease (NED) Status in Metastatic Colorectal Cancer (mCRC) and Its Utility in Guiding Therapeutic Intervention: an Open-label, Prospective, Phase II Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Colorectal Cancer
No Evidence of Disease Status
ctDNA Monitoring
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Dx Co., Ltd.
First posted: 2022-12-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are:

1. Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring?
2. Whether the patients with ctDNA positive status could benefit from early therapeutic intervention.

Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old. Both male and female are eligible.
2. Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology.
3. With potential opportunity of achieving NED status (including liver metastasis, lung metastasis, solitary lymph node metastasis, ovarian metastasis or focal pelvic metastasis), regardless of neo-adjuvant therapy or transforming therapy.
4. Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy)
5. Eastern Cooperative Oncology Group (ECOG) grade 1-2.
6. Approve the informed consent.
7. Available for tumor sample obtained by resection or aspiration.
8. Available for peripheral blood collection (10mL per tube for 2 tubes)

Exclusion Criteria:

1. Cannot get histologic or cytologic diagnosis.
2. Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition.
3. Accompany with widespread metastasis and cannot achieve NED status by focal therapy, such as bone metastasis, peritoneum metastasis, diffuse liver or lung metastasis or malignant effusion, etc.
4. Inadequate bone marrow reserve and organ function.
5. Uncontrolled or severe systemic diseases, such as uncontrolled hyperplasia, severe infection, hepatitic B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, etc.
6. History of alcohol or drug abuse.
7. Pregnant or lactating women.
8. Cannot get tumor sample.

Primary outcomes:
measure: Relapse-free survival (RFS) time
timeFrame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Secondary outcomes:
measure: Overall survival (OS) time
timeFrame: From the date of surgery until the date of death from any cause, assessed up to 2 years.
measure: The positive rate of ctDNA in mCRC patients with NED status.
timeFrame: Post-operation 1 month
measure: The concordance index of ctDNA defined NED and radiology defined NED status.
timeFrame: When the clinic trail is finished, up to 2 years.
measure: The rate of achieving NED status when relapses happen.
timeFrame: When the relapses happen, up to 2 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: