Rectal cancer
Conditions
Interventions
Experimental group:Irinotecan liposomes combined with long-term radiotherapy and chemotherapy, sequentially 8 cycles of Irinotecan liposomes+mFOLFOX6
Control group:Long term chemoradiotherapy, sequential 8 cycles of mFOLFOX6
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, <=75 years old; 2. Confirmed by histopathological diagnosis of rectal adenocarcinoma; 3. Clinical stage of T3-4 or N as assessed by MRI (according to AJCC 8th edition); 4. The distance between the lower edge of the tumor and the anal margin <=10cm; 5. ECOG (Eastern Oncology Collaboration) score is 0~1 points; 6. The phenotypes of UGT1A1*6 and UGT1A1*28 genes were all-wild-type (GG 6/6) or single-point mutant (GG 6/7 or GA 6/6); 7. Have not received any anti-tumor therapy for rectal cancer in the past, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; 8. Normal function of major organs; 9. Female subjects of childbearing potential should have a serum pregnancy test within 72 hours before starting the trial drug administration, and the result is negative, and take effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the trial and for at least 3 months after the last dose; For male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial and for 3 months after the last dose; 10. Voluntarily participate in this study and sign the informed consent form, with good compliance, and agree to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Have previously undergone or are currently undergoing any surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, etc. for rectal tumors; 2. MSI-H or immunohistochemical testing for dMMR; 3. Have undergone major surgery or suffered serious trauma within 4 weeks prior to the first use of the investigational drug; 4. Concomitant medications containing strong CYP3A4 inhibitors/inducers or strong UGT1A1 inhibitors Within the first 2 weeks of randomization; 5. It is known that there are allergic reactions, hypersensitivity reactions, or contraindications to any of Irinotecan liposomes/mimetics, Irinotecan, other liposome products, 5-FU, calcium folinate, or oxaliplatin; 6. Clinical symptoms or diseases of the heart that have not been well controlled, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention; 7. Within the first 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE>grade 2), such as severe pneumonia, bacteremia, and infection complications that require hospitalization; 8. Severe gastrointestinal dysfunction (inflammation or diarrhea greater than grade 1); 9. Interstitial lung disease, except for interstitial changes shown only by imaging. 10. Diagnosed with other malignant tumors within 5 years prior to the first use of the investigational drug, unless there is a low-risk metastasis or death risk malignant tumor (5-year survival rate>90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ, may be considered for inclusion; 11. Pregnant or lactating women; 12. According to the researchers' assessment, there are other factors that may lead to forced termination of the study, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, alcohol abuse, drug abuse, family or social factors, which may affect the safety or compliance of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event-free survival rate; | — |
Countries
China
Contacts
Public ContactZhu Ji
Zhejiang Cancer Hospital
Outcome results
None listed