The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Location status: Recruiting
Location contact
Yanxin Luo, PhD,MD
CONTACT
Yaoyi Huang, BS
CONTACT
NCT Number: NCT05797077
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Guangzhou, Guangdong, China
Location status: Recruiting
Yanxin Luo, PhD,MD
CONTACT
Yaoyi Huang, BS
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colorectal cancer radical resection combined with liver metastasis resection or ablation.
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Other names: CapeOx chemotherapy regimen
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.
Other names: 5-FU/LV
Time frame: 3 years after operation.
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Time frame: 5 years after operation.
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Time frame: 3 years after operation.
Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Time frame: 5 years after operation.
Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Time frame: 5 years.
he complications of adjuvant therapy usually refer to the adverse events that occur during or after treatment, including but not limited to chemotherapy-related adverse reactions, radiation therapy-related adverse reactions, and postoperative complications. Specifically, chemotherapy-related adverse reactions may include nausea, vomiting, diarrhea, anemia, and infections; radiation therapy-related adverse reactions may include skin inflammation, nausea, vomiting, diarrhea, fatigue, and dry mouth; postoperative complications may include bleeding, infection, intestinal obstruction, and poor wound healing. Researchers typically record the types, severity, and impact of these complications on treatment to evaluate the safety and tolerability of adjuvant therapy.
Sixth Affiliated Hospital, Sun Yat-sen University
Other
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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