rectal cancer
Conditions
Interventions
Research group:Irinotecan liposomes, concurrent chemoradiotherapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed as rectal adenocarcinoma by histopathology, immunohistochemical pMMR or MSI-L, MSS; 2.The baseline clinical staging is T3-4 and/or N+; 3.The distance between the tumor and the anus is<=10cm; 4.No distant metastasis; 5.Age range from 18 to 70 years old; 6.ECOG PS score 0-1 points; 7.The UGT1A1 * 6 and UGT1A1 * 28 gene phenotypes are all wild-type (GG+6/6), unit point mutant (GG+6/7 or GA+6/6), and dual site mutant (GG+7/7 or AA+6/6 or GA+6/7); 8.Not receiving chemotherapy or any other anti-tumor treatment before enrollment; 9.Able to adhere to the protocol during the research period; 10.Sign written informed consent;
Exclusion criteria
Exclusion criteria: 1.Diagnosed as rectal adenocarcinoma by histopathology, with immunohistochemical dMMR or MSI-H; 2.UGT1A1 * 6, UGT1A1 * 28 gene phenotype three site mutations (AA+7/7 or AA+6/7 or GA+7/7); 3.Pregnant or lactating women; 4.Individuals with a history of other malignant diseases in the past 5 years, excluding cured skin cancer and cervical cancer in situ; 5.Individuals with a history of uncontrolled epilepsy, central nervous system disease, or mental disorders, whose clinical severity may be assessed by the researcher as hindering the signing of informed consent forms or affecting the patient's adherence to oral medication; 6.Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention (see Appendix 12), or a history of myocardial infarction within the past 12 months; 7.Organ transplantation requires immunosuppressive therapy for patients; 8.Severe uncontrolled recurrent infections or other serious uncontrolled comorbidities; 9.The baseline blood routine and biochemical indicators of the subjects do not meet the following criteria: hemoglobin = 90g/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; ALT and AST = 30g/L; 10.Known to suffer from dihydropyrimidine dehydrogenase (DPD) deficiency; 11.Individuals who are allergic to any research medication;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD(Maximal Tolerable Dose); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Countries
China
Contacts
Public ContactZhu Ji
Zhejiang Cancer Hospital
Outcome results
None listed