rectal cancer
Conditions
Interventions
experimental group:anoliposomal irinotecan combined with oxaliplatin and fluorouracil
/leucovorin
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Age =18 years old and =75 years old; (2)ECOG performance status of 0-1; (3)Biopsy and pathology confirmed rectal adenocarcinoma; (4)It was determined by MRI that the lower margin of the primary tumor was 5cm~15cm at the anal margin (excluding 5cm) (5)The clinical stage was T3NanyM0 or T2N+M0; (6) EMVI+/- ,MRF-; (7) Bone marrow function :Absolute neutrophil count ( ANC ) =1.5×10^9/L;Hemoglobin ( Hb ) =70g/L;Platelet count ( PLT ) =100×10^9/L; (8) Liver function:spartate aminotransferase ( AST ) = 2.5 × ULN. Alanine aminotransferase ( ALT ) = 2.5 × ULN. (AST and ALT =5×ULN in patients with liver metastasis); Serum albumin =3 g/dL; (9) Renal function: serum creatinine=1.5×ULN,and Creatinine clearance rate = 60mL / min ( calculated according to the Cockcroft-Gault formula ) (10)Accept the neoadjuvant chemotherapy protocol of this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1)Positive lateral lymph nodes were excluded; (2)patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma. (3)Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment; (4)Combined with uncontrollable systemic diseases; (5)Those who are known to be allergic or intolerant to the drugs or excipients treated in this study protocol; (6)Chemotherapy and surgery contraindicated by any clinical indicator; (7)Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or UGT1A1; (8)Women who are pregnant or breastfeeding, and patients of childbearing age who refuse to take appropriate contraceptive measures during the trial; (9)Patients treated with radiotherapy, chemotherapy other than in this study, immunotherapy, targeted therapy, Chinese herbal medicine, etc. (10)Patients who have participated in other clinical trials within the first 4 weeks of enrollment. (11)The researchers believe that there are other factors that are not suitable for the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission, MPR;R0 resection rate;objective response rate, ORR;disease control rate, DCR;Disease-free survival, DFS; | — |
Countries
China
Contacts
Public ContactYanlai Sun
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed