Phase II Study of Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy for Patients with Locally Advanced Colorectal Cancer
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.
• With a full understanding of the study, each participant volunteered to participate in this study and signed the informed consent (ICF) with good compliance and follow-up.
• Age ≥18 and ≤70.
• ECOG physical status score is 0 or 1.
• Expected survival period ≥ 12 weeks.
• Patients with histopathological confirmed MSS/pMMR-type adenocarcinoma of the colon and upper rectum which is not amenable to radiotherapy.
• R0 resection was expected to be achieved by necessarily combined organ resection, or R0 resection cannot be achieved, assessed by CT and/or MRI and multidisciplinary team (MDT) discussion.
• The clinical stage was cT4N1-2M0 or cT4bN0M0 according to AJCC 8th edition.
• Patients with multiple primary colorectal cancer are eligible, if one of the primary tumors meets the inclusion criteria.
• Patients with intestinal obstruction was relieved by colonic stenting or ostomy.
⁃ Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
⁃ At least one evaluable lesion (according to RECIST v1.1 standard);
⁃ Adequate organ function according to the following laboratory test values:
∙ Hemoglobin value ≥90g/L.
‣ White blood cell count ≥3.5\*109/L.
‣ Absolute neutrophil count ≥1.5\*109/L.
‣ Platelet count ≥100\*109/L.
‣ Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.
‣ Total serum bilirubin ≤1.5 upper normal limit (ULN).
‣ Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 upper limit of normal value (ULN).
⁃ Women with reproductive potential (\< 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.