Colorectal resection surgery.: Colorectal cancer radical resection combined with liver metastasis resection or ablation.
FOLFOX chemotherapy regimen: Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Capecitabine: Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)
3-years Progression Free Survival — 3 years after operation. PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
5-years Progression Free Survival — 5 years after operation. PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Trial sites (1)
Facility
City
Region
Status
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou
Guangdong
Recruiting
More Sixth Affiliated Hospital, Sun Yat-sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.