Actively Recruiting
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2023-04-04
346
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with colorectal cancer that has spread to the liver and can be surgically removed. The study aims to find out if patients who test positive for circulating tumor DNA (ctDNA) after surgery have better progression-free survival when given a combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone. This is a phase III randomized controlled trial focusing on improving outcomes after surgery by targeting residual cancer cells detected by ctDNA. Participants will undergo colorectal cancer surgery with liver metastasis removal or ablation. After surgery, patients with positive ctDNA results are randomly assigned to receive either standard adjuvant chemotherapy alone or adjuvant chemotherapy combined with maintenance therapy using low-toxicity drugs such as capecitabine or 5-FU/LV, possibly with targeted therapy. Maintenance treatment continues until ctDNA tests turn negative. The trial compares these two approaches over several years. During the study, participants will be monitored for progression-free survival at 3 and 5 years after surgery, along with overall survival and long-term complications for up to 5 years. Assessments include regular follow-ups to track disease status and safety. The study collects detailed data to understand the benefits and risks of adding maintenance therapy for ctDNA-positive patients after liver metastasis surgery in colorectal cancer.
CONDITIONS
Brief Title
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Diagnosed with liver metastatic colorectal cancer and undergone complete tumor removal (R0 resection) or ablation with similar effect
- Positive circulating tumor DNA (ctDNA) test after surgery
- ASA grade less than IV and/or ECOG performance status score 2 or less
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Presence of distant metastases outside the liver, such as pelvis, ovaries, or peritoneum
- History of other malignant tumors
- Severe dysfunction of liver, kidney, heart, lungs, or blood clotting that prevents chemotherapy
- Allergy to any study treatment components
- Previous investigational drug treatments for tumors
- Severe uncontrolled infections or other serious diseases
- Other factors affecting study results or causing early withdrawal, including alcoholism, drug abuse, mental illness, or severe lab abnormalities
- History of severe mental illness
- Pregnant or breastfeeding women
- Any other clinical or lab conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo colorectal cancer radical resection combined with liver metastasis resection or ablation.
1 surgical procedure and hospitalization period
Duration - Several months until ctDNA negativity
Participants receive adjuvant chemotherapy with oxaliplatin-based regimens such as FOLFOX or CapeOx, or single-agent chemotherapy, followed by maintenance therapy with low-toxicity drugs like capecitabine or 5-FU/LV, which may be combined with targeted therapy. Maintenance therapy continues until ctDNA testing is negative.
Regular chemotherapy visits followed by maintenance therapy visits
Duration - Up to 5 years
Participants are monitored for disease progression, survival, and complications for up to 5 years after surgery.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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