ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
Patients with negative ctDNA after surgery;
ASA grade <IV and/or ECOG performance status score ≤ 2;
Disqualifiers
Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
Patients with a history of other malignancies;
Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
Patients who are allergic to any component in the study;
Trial design
Treatments tested in this trial
- Colorectal cancer resection combined with liver metastasis resection.
- FOLFOX chemotherapy regimen
Treatment groups
490 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov