Maintenance therapy for colorectal cancer patients after liver surgery

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

This study is testing if adding maintenance therapy to standard chemotherapy can help colorectal cancer patients with liver metastases live longer without their cancer getting worse after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05797077 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a combination of adjuvant chemotherapy and maintenance therapy against adjuvant chemotherapy alone in patients with resectable liver metastases from colorectal cancer. The study focuses on patients who test positive for circulating tumor DNA (ctDNA) after surgery. By evaluating progression-free survival (PFS), the trial seeks to determine if the additional maintenance therapy can improve outcomes for these patients. The intervention includes colorectal resection surgery followed by the FOLFOX chemotherapy regimen and Capecitabine.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resectable liver metastatic colorectal cancer who are ctDNA-positive after surgery.

Not a fit: Patients with distant metastases to other sites or those with severe underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the survival rates and quality of life for patients with resectable liver metastases from colorectal cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in the use of ctDNA for guiding therapy in cancer treatment.

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.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Conditions Colorectal Cancer; Liver Metastases; Circulating Tumor Cell; Cancer, Therapy-Related; ctDNA; maintenance therapy