Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients.
After patients are enrolled, they will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGOrgan-sparing R0 Resection Rate
The proportion of patients achieved R0 resection by only resecting the colon while other organs were retained.
Time frame: 2 years
ypTNM stage
ypTNM stage evaluated by pathologists
Time frame: 2 years
TRG
Tumor regression grade evaluated by pathologists
Time frame: 2 years
R0, R1, R2 resection rate
R0, R1, R2 Resection Rate
Time frame: 2 years
Rate of residual or recurrent disease occurring within 2 years after surgery
The proportion of patients who experienced residual or recurrent disease within 2 years after surgery.
Time frame: 2 years
3-year OS rate
The proportion of patients achieved 3-year survival from treatment.
Time frame: 3 years
3-year PFS rate
The proportion of patients did not progress at least 3 years from treatment.
Time frame: 3 years
Safety and Tolerability
Incidence of Treatment-Related Adverse Events
Time frame: 2 years
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