Locally advanced rectal cancer
Conditions
Interventions
Experimental group:Irinotecan liposome + Oxaliplatin + Calcium folinate + 5-FU
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent form (Informed Consent Form, ICF) and be able to comply with the visit and related procedures stipulated in the protocol; 2. Age >= 18 years old; 3. Histologically confirmed as primary rectal cancer; 4. Known as RAS or BRAF mutant type; 5. The pMMR/MSS or MMR/MS status is unknown; 6. According to the eighth edition of the AJCC staging system, after imaging assessment (enhanced CT or enhanced MRI), it is a surgically resectable T3-4N0M0 or TxN+M0 locally advanced rectal cancer patient; 7. Diagnosed by the investigator, the lesion can undergo radical resection (R0 resection) before neoadjuvant treatment; 8. According to the RECIST v1.1 assessment criteria, there is at least 1 evaluable lesion; 9. Eastern Cooperative Oncology Group performance status (ECOG PS) of the United States is 0-1; 10. Have sufficient organ and bone marrow functions, defined as follows: Blood routine: Neutrophil count (Absolute Neutrophil Count, ANC) >= 1.5×10^9 /L; Platelet (Platelet, PLT) >= 100×10^9/L; Hemoglobin (Hemoglobin, HGB) >= 7.5 g/dL Liver function: Serum total bilirubin (Total Bilirubin, TBIL) = 28 g/L Kidney function: Serum creatinine = 50 ml/min (calculated by Cockcroft-Gault or standard 24-hour urine method); Urine test paper detection shows that urine protein < 2+; For subjects whose urine test paper detection shows urine protein = 2+ at baseline, 24-hour urine collection should be conducted and the protein content in urine within 24 hours should be < 1g. Coagulation function: International Normalized Ratio (International Normalized Ratio, INR) <= 1.5, and activated partial thromboplastin time (Activated partial thromboplastin time, APTT) <= 1.5×ULN. Some anticoagulant drugs (such as antiplatelet aggregation drugs, vitamin K antagonists, etc.) should be discontinued 7-14 days before surgery and replaced with other drugs (such as low molecular weight heparin). 11. There are no serious diseases that seriously endanger the survival of the subjects (resulting in the expected survival time of the subjects < 5 years); 12. For female subjects of childbearing age or male subjects whose partners are of childbearing age, effective contraceptive measures should be taken throughout the treatment period and for 6 months after the treatment. The female subjects had evidence of post-menopausal status, or the urine or serum pregnancy test results of pre-menopausal female subjects were negative. 13. No peripheral neuropathy (grade < 2); 14. No known history of dihydropyridine dehydrogenase deficiency (DPD).
Exclusion criteria
Exclusion criteria: 1. Has received any anti-tumor treatment for the studied disease before, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; 2. Is concurrently participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the survival follow-up stage of an interventional study; 3. Has received any investigational drug or investigational device treatment within 4 weeks before the first administration of the study drug; 4. Has undergone major surgical procedures (such as craniotomy, thoracotomy or laparotomy) within 4 weeks before the first administration of the study drug, and is expected to require major surgery during the study treatment (except for the radical resection of colon cancer as stipulated in the protocol), or has unhealed wounds, ulcers or fractures; 5. Has known active or suspected autoimmune diseases or has a history of autoimmune diseases within the past 2 years (except for eczema, vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment within the past 2 years, only thyroid hormone replacement therapy for hypothyroidism or autoimmune hypothyroidism history, and type 1 diabetes with only insulin replacement therapy, these can be enrolled); 6. Is expected to require short-term clinical intervention for ascites and pleural effusion, or has clinical symptoms or requires drainage of pericardial effusion; 7. Has experienced a severe infection or is in the active stage or has poor clinical control within 4 weeks before the first administration of the study drug, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia; Has received therapeutic oral or intravenous antibiotics within 2 weeks before the first administration of the study drug; 8. Symptomatic congestive heart failure (New York Heart Association grade II-IV) or echocardiography indicating a left ventricular ejection fraction (Left Ventricular Ejection Fraction, LVEF) 500 ms (calculated using the Fridericia method); 9. Even with standard treatment, the arterial hypertension is still uncontrolled (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg), hypertensive crisis or history of hypertensive encephalopathy; 10. Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy; 11. Has a history of gastrointestinal perforation and/or fistula within 6 months before the first administration of the study drug; 12. Intestinal obstruction (excluding incomplete intestinal obstruction that only requires enteral nutrition); Subjects with a risk of intestinal perforation (including but not limited to acute diverticulitis, abdominal abscess, history of abdominal cancer); 13. History of the following diseases: extensive bowel resection (partial colon resection or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea; 14. Other primary malignant tumor history, except for: cured malignant tumors, without known active disease within 2 years before the first administration of the study drug and with a very low risk of recurrence; non-melanoma skin cancer or malignant lentigo-like nevus that has been adequately treated and without evidence of disease recurrence; in situ cancer that has been adequately treated and without e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 Resection Rate;Overall survival;Event-free survival;Tumor regression grading; | — |
Countries
China
Contacts
Public ContactLiu Gang
Tianjin Medical University General Hospital
Outcome results
None listed