rectal cancer
Conditions
Interventions
Test Group A:Long-course concurrent chemoradiotherapy, followed by 8 cycles of liposomal irinotecan (II) (60 mg/m2) + mFOLFOX6.
Test Group B:Long-course concurrent chemoradiotherapy, followed by 8 cycles of liposomal irinotecan (II) (50 mg/m2) + mFOLFOX6.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male or female. 2. Histopathologically confirmed rectal adenocarcinoma, with immunohistochemistry indicating pMMR or genetic testing indicating MSS. 3. Clinical stage assessed by MRI as cT3-4N0M0 or cT1-4N+M0 (according to AJCC 8th Edition). 4. Lower edge of tumor = 1.5 × 10?/L * Platelet count >= 100 × 10?/L * Hemoglobin >= 90 g/L b) Blood biochemistry: * Total bilirubin = 50 mL/min c) Coagulation function: * International Normalized Ratio (INR) <= 1.5 × ULN * Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN 8. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug(s) and must use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for at least 6 months after the last dose of liposomal irinotecan/other chemotherapy drugs (whichever is longer). Male subjects with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose of liposomal irinotecan/other chemotherapy drugs (whichever is longer). Sperm donation is not permitted during the study period. 9. Voluntary participation in this study with signed informed consent form, good compliance, and agreement to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous or current treatment for the tumor with surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2. Known genetic testing results indicating MSI-H (Microsatellite Instability-High) or immunohistochemistry results indicating dMMR (Mismatch Repair Deficiency). 3. Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug(s). 4. Concomitant medication within 2 weeks prior to randomization containing strong inhibitors/inducers of CYP3A4 or strong inhibitors of UGT1A1. 5. Known allergy, hypersensitivity, or contraindication to liposomal irinotecan/its placebo, irinotecan, other liposomal products, 5-FU, calcium folinate (leucovorin), or oxaliplatin. 6. Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure of NYHA Class II or above, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention. 7. Serious infection (CTCAE > Grade 2) within 4 weeks before the first dose of the study drug(s), such as severe pneumonia requiring hospitalization, bacteremia, or complicated infections; presence of active pulmonary inflammation indicated by baseline chest imaging; OR signs and symptoms of infection within 14 days prior to the first dose of the study drug(s) requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use). 8. Severe gastrointestinal disorders (inflammation or diarrhea greater than Grade 1). 9. Known interstitial lung disease, excluding incidental radiographic findings without clinical symptoms. 10. History of another malignant tumor diagnosed within 5 years prior to the first dose of the study drug(s), except for malignancies with a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, for which enrollment may be considered. 11. Pregnant or lactating women. 12. Any other factors identified by the investigator that could lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, alcohol abuse, drug abuse, familial or social factors, or circumstances that could compromise subject safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete total neoadjuvant treatment;Rate of Organ preservation;Local Recurrence-Free Survival;Distant Metastasis-Free Survival;Overall Survival;the rate of adverse event;the rate of postoperative complication;Correlation of Potential Biomarkers with Treatment Efficacy;the quality of life; | — |
Countries
China
Contacts
Public ContactYi Xiao
Peking Union Medical College Hospital
Outcome results
None listed