Patients with histologically confirmed, imaging-assessed progressive colon cancer (cT4N1-2M0) and mid- to upper-segment rectal cancer (cT3-4N0-2M0, MRF+EMVI+) who are assessed to be able to be resected in R0 with preservation of anal function
Conditions
Interventions
Irinotecan liposome group:NALIRINOX treatment
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria: age:18-75 years old gender: male or female; 2.ECOG 0-2; 3.no distant metastasis (distant organ or (and) distant lymph node metastasis) as assessed by CT scanning or other radiological examinations; 4.colon cancer (cT4N1-2M0) and upper-middle segment rectal cancer (cT3-4N0-2M0) that was diagnosed histologically confirmed and assessed by imaging to be in a progressive stage, and patients who were assessed to have R0 resection with preservation of anal function, and for T4b patients, R0 resection was expected through MDT discussions, including combined organ resections if necessary , MRF+ or EMVI+) who have been evaluated for R0 resection with preservation of anal function, and for T4b patients, R0 resection is expected through MDT discussion, including combined organ resection if necessary; 5.no history of allergy to 5-Fu and platinum as well as irinotecan or liposomal medications; 6.adequate bone marrow function: Hb>9g/dl, PLT>100 x 10^9/l , WBC>3.5 x 10^9/l, ANC=1.5x10^9/l; 7.adequate hepatobiliary function: AST (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limit of normal) or lower, alkaline phosphatase of 2.5 x ULN or lower, and total bilirubin of 1.5 x upper limit of normal or lower; 8.adequate renal Biochemistry: glomerular filtration rate >50 ml/min or EDTA clearance >70 ml/min as calculated by the Wright or Cockroft formula; 9.For females and patients of childbearing potential, the patient must undergo a negative pregnancy test =72 hours prior to initiation of study treatment and agree to avoid pregnancy during and for 6 months after study treatment. For males with partners of childbearing potential, patients must agree to use adequate, medically approved contraceptive prophylaxis during and for 90 days after the last study treatment; 10.Patients are able and willing to provide written informed consent for the study.
Exclusion criteria
Exclusion criteria: 1. rectal cancer located 5 cm or less from the anal verge, invading adjacent organs and not amenable to R0 resection; 2.any patient for whom radiation therapy is recommended by the MDT; 3.patients with evidence of distant metastases or peritoneal nodes (M1); 4.patients with dMMR and MSI-H; 5.patients with a BRAF mutation; 6.a serious bowel complication as assessed by the initial clinical or imaging evaluation: perforation , obstruction, uncontrolled bleeding; 7.another serious medical condition judged to affect the ability to tolerate neoadjuvant therapy and/or surgery; 8.prior or concurrent malignancies (including concurrent cancers) other than cured basal cell carcinoma of the skin and cervical carcinoma in situ; 9.pregnant or lactating women; 10.patients with severe cardiovascular disease and diabetes mellitus not readily controlled; 11.Patients with psychiatric disorders; 12.Patients with severe infections; 13.Patients receiving thrombolytic/anticoagulant therapy with bleeding qualities or coagulation disordersor aneurysms, stroke, transient ischemic attack, or arteriovenous malformations; 14.Patients with a history of prior renal disease with urinary proteins on urinalysis or clinically significant renal function abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median number of treatment cycles;Completion of the 4/8 cycle rate;Disease-free survival (DFS);Degradation rates: degradation of T and N;R0 excision rate;Grade 3-4 adverse reactions;2-year recurrence rate;Degree of tumor regression (TRG); | — |
Countries
China
Contacts
Public ContactLiren Li
Sun Yat-sen University Cancer Center
Outcome results
None listed