Localized advanced rectal adenocarcinoma
Conditions
Interventions
Experimental group:Subjects who meet the research criteria will receive long-term synchronous radiotherapy and chemotherapy, with a total radiation dose of 50 Gy/25 times, once a day, 5 times a week,
Irinotecan liposomes: intravenous infusion at a dose of 40 mg/m 2, administered once at weeks 1, 3, and 5, respectively. Chemotherapy will be administered after a two-week interval.
Sponsors
Tianjin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Fully understands this study and voluntarily signs the informed consent form, complies well, and cooperates with follow-up;2. Aged >= 18 years and = 12 weeks; 5. Histopathologically confirmed rectal adenocarcinoma; known to be pMMR and/or MSS; 6. Non-metastatic cancer that requires combined organ resection to achieve R0 resection, or even with combined organ resection cannot achieve R0 resection, evaluated by CT and/or MRI and a multidisciplinary team; 7. Clinical staging of T3-T4 or N; 8. The distance from the lower edge of the tumor to the anal edge is = 90 g/L; 2) Absolute Neutrophil Count (ANC) >= 1.5×10^9 /L; 3) Platelet Count (PLT) >= 100×10^9 /L; (2) Biochemical examination must meet the following criteria: 1) Total Bilirubin (TBIL) 60 mL/min (using the Cockcroft-Gault formula); 4) Urinalysis shows Urinary Protein (UPRO) = the lower limit of normal (50%); (4) Coagulation function: International Normalized Ratio (INR) <= 1.5×ULN and activated Partial Thromboplastin Time <= 1.5×ULN; 13. Women of childbearing age must agree to use effective contraceptive measures during the study and for 6 months after the study ends; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be lactating; men must agree to use contraceptive measures during the study and for 6 months after the study ends.
Exclusion criteria
Exclusion criteria: 1. Allergies to irinotecan liposomes, other liposome products, platinum drugs, fluorouracil and other therapeutic drugs; 2. Participated in clinical trials of other drugs within the four weeks prior to enrollment; 3. Suffering from other malignant tumors within 5 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 4. dMMR/MSI-H patients; 5. Known peripheral neuropathy (CTCAE >= grade 3); 6. Have a history of bleeding and have experienced any severe grading of CTCAE 5.0 within the 4 weeks prior to screening; 7. Suffering from FAP, HNPCC or inflammatory bowel disease; Severe gastrointestinal dysfunction; 8. Patients with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess, and non gastrointestinal fistula (such as tracheoesophageal fistula) within 6 months before enrollment; 9. It is known that there is interstitial lung disease, except for interstitial changes shown only by imaging; 10. Patients known to have central nervous system metastases or a history of central nervous system metastases prior to screening. For patients suspected of having central nervous system metastases in clinical practice, prior to randomization Enhanced CT or MRI examination must be performed within 28 days to rule out central nervous system metastasis; 11. Within the first 2 weeks of randomization, concomitant medication contains strong inhibitors/inducers of CYP3A4, CYP2C8, or UGT1A1; 12. Patients with hypertension who cannot achieve good control with single antihypertensive medication (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); Individuals with a history of unstable angina pectoris; Newly diagnosed with angina pectoris within the first 3 months of screening or experiencing myocardial infarction events within the first 6 months of screening; Arrhythmia (including QTcF: >= 450 ms for males and >= 470 ms for females) requires long-term use of antiarrhythmic drugs and New York Heart Association classification of >= II heart failure; 13. Patients with abnormal coagulation function and bleeding tendency (must meet the requirement of INR being within the normal range without using anticoagulants within 14 days before enrollment); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the condition that the International Normalized Ratio (INR) of prothrombin time is =500 IU/mL), Hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the upper limit of normal); Known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event-free survival period (EFS);Overall Survival (OS);3-year disease-free survival (DFS); | — |
Countries
China
Contacts
Public ContactHao Yan
Tianjin People's Hospital
Outcome results
None listed