Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD)
Status:
Not yet recruiting
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
Summary
Surgery is the main treatment method for colon cancer. About 50% of patients can be cured
with surgery alone. For colon cancer with high-risk stage II or III after surgery, the
current guidelines recommend 3-6 months after surgery. adjuvant chemotherapy to reduce the
risk of recurrence and metastasis. However, for this part of the population, the overall
benefit of adjuvant chemotherapy is limited, and different high-risk factors have different
weights; some patients will still experience recurrence and metastasis even after receiving
adjuvant chemotherapy. A number of previous studies have shown that patients with a positive
ctDNA test on postoperative liquid biopsy without postoperative adjuvant therapy have a
recurrence risk of 70-80%. Even if they receive adjuvant chemotherapy, the recurrence risk is
significantly higher than that of ctDNA-negative patients. ctDNA has received increasing
attention as a predictor of postoperative recurrence risk.
This study intends to randomly assign 1:1 to mFOLFOXIRI regimen adjuvant chemotherapy for 6
months and mFOLFOX6 regimen for colon cancer patients with postoperative high-risk stage
II-III and liquid biopsy results within 1 month after surgery. Adjuvant chemotherapy was
performed for 6 months, ctDNA was dynamically monitored after 3 months of treatment and at
the end of adjuvant therapy. During the follow-up period, CEA was reviewed every 3 months,
and chest, abdomen, and pelvis CT and ctDNA were reviewed every 6 months; the primary
endpoint of the study was 2 years RFS, secondary endpoints included 3-year DFS, OS, safety
and tolerability. Through intensive postoperative adjuvant therapy, we hope to screen colon
cancer patients with high recurrence risk to receive adjuvant chemotherapy and improve the
survival prognosis of ctDNA-positive colon cancer patients.