Clinical trial NCT05797077: Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
Official title: Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Liver Metastases
Circulating Tumor Cell
Cancer, Therapy-Related
Keywords: Colorectal Cancer
Liver Metastases
ctDNA
maintenance therapy
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

1. Both males and females, aged 18-75 years;
2. Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);
3. Postoperative ctDNA-positive patients;
4. ASA grade \< IV and/or ECOG performance status score ≤ 2;
5. Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
2. Patients with a history of other malignant tumors.
3. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
4. Patients who are allergic to any component of the study.
5. Patients who have received other tumor-related investigational drug treatments.
6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
7. Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities.
8. Patients with a history of severe mental illness.
9. Pregnant or lactating women.
10. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Primary outcomes:
measure: 3-years Progression Free Survival
timeFrame: 3 years after operation.
measure: 5-years Progression Free Survival
timeFrame: 5 years after operation.
Secondary outcomes:
measure: 3-years overall survival
timeFrame: 3 years after operation.
measure: 5-years overall survival
timeFrame: 5 years after operation.
measure: Complication
timeFrame: 5 years.
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: