Actively Recruiting
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2023-04-18
490
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.
CONDITIONS
Official Title
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years of any gender who have received neoadjuvant chemotherapy
- Patients with liver metastatic colorectal cancer who have undergone complete (R0) resection confirmed by multidisciplinary team evaluation
- Patients with negative circulating tumor DNA (ctDNA) results after surgery
- Patients with ASA grade less than IV and/or ECOG performance status score 2 or less
- Patients capable of understanding the study and who voluntarily sign informed consent
You will not qualify if you...
- Patients with distant metastases outside the liver, such as pelvic, ovarian, or peritoneal metastases
- Patients with a history of other cancers
- Patients with severe dysfunction of liver, kidney, heart, or lung or coagulation disorders that prevent chemotherapy
- Patients allergic to any study components
- Patients who have received other investigational cancer treatments
- Patients with severe uncontrolled infections or other serious uncontrolled diseases
- Patients with factors that could affect study results or cause early withdrawal, including alcoholism, drug abuse, serious diseases requiring complex treatment, or abnormal lab tests
- Patients with a history of severe mental illness
- Pregnant or breastfeeding women
- Patients deemed unsuitable for participation by the investigator due to clinical or laboratory reasons
AI-Screening
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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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