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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Colorectal cancer resection combined with liver metastasis resection.
Procedure/SurgeryThe preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection.
FOLFOX chemotherapy regimen
DrugChemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Treatment groups
490 Participants
are divided into 2 treatment groupsGroup A: Watching and waiting groupExperimental treatment 1 intervention
Group B: Adjuvant chemotherapy groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
3-year progression-free survival
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.2
5-year progression-free survival
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.Secondary outcomes
1
3-year overall survival
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
3 years after operation.2
3-year overall survival
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.3
Complications
When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death).
Time frame
5 years.Sponsors and contacts
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Source ClinicalTrials.gov