Colorectal cancer
Conditions
Interventions
Experimental Group:IOLF regimen (Irinotecan + Oxaliplatin + 5-Fluorouracil)
Serplulimab
Bevacizumab
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Histologically confirmed, initially resectable colorectal cancer. 3. No prior history of systemic anti-tumor drug therapy for colorectal cancer. 4. Willing to undergo radical surgery and deemed free of surgical contraindications by a surgeon. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Life expectancy > 6 months. 7. For female participants of childbearing potential, a negative urine or serum pregnancy test is required within 3 days prior to the first dose of the study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. 8. All participants (male or female) at risk of conception must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period and until 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy). 9. Adequate function of major organs, meeting the following requirements (no use of blood components or hematopoietic growth factors is allowed within 14 days prior to enrollment): Absolute neutrophil count (ANC) > 1,000/µL; Platelet count > 50,000/µL; Hemoglobin > 8 g/dL; Total bilirubin level < 3 times the upper limit of normal (ULN).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other malignancies besides colorectal cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 2. Known endoscopic evidence of active bleeding from the lesion; 3. Hypersensitivity to any of the drugs in this study protocol; 4. Concurrent other malignancies; 5. Concurrent severe cardiac, hepatic, renal, or hematological diseases; 6. History of stroke; 7. Concurrent severe psychiatric disorders; 8. Currently participating in an interventional clinical study, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; 9. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 10. Received systemic treatment with traditional Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for controlling pleural effusion) within 2 weeks prior to the first dose; 11. Active autoimmune disease requiring systemic treatment (e.g., use of corticosteroids or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; 12. Receiving systemic corticosteroid therapy (excluding nasal spray, inhalation, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug. Note: Use of physiological doses of corticosteroids (=10 mg/day of prednisone or equivalent) is allowed; 13. Severe malnutrition; 14. International Normalized Ratio (INR) > 1.5 or Activated Partial Thromboplastin Time (APTT) > 1.5 × ULN; 15. Patients with autoimmune diseases who have received immunosuppressants (such as corticosteroids, methotrexate, TNF inhibitors, etc.) or biologics within the past 2 years; 16. ECOG performance status >= 3; 17. Known dihydropyrimidine dehydrogenase (DPD) deficiency; 18. Untreatable central nervous system metastases; 19. Clinically significant electrolyte abnormalities as determined by the investigator; 20. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 21. Peripheral neuropathy > Grade 3; 22. History of hypertensive crisis or hypertensive encephalopathy; uncontrolled hypertension prior to enrollment, defined as: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure = 90 mmHg; 23. History of severe allergy: Grade 4 or higher allergic reaction (CTCAE V5.0) to macromolecular protein preparations/monoclonal antibodies or study drug components; 24. Untreated active hepatitis B (defined as HBsAg positive and detected HBV-DNA copy number greater than the upper limit of normal of the research center's laboratory); Note: Hepatitis B participants meeting the following criteria may also be enrolled: a) HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose, participants should receive anti-HBV treatment during the entire study chemotherapy period to prevent viral reactivation; b) For participants with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), preventi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response rate;Major Pathologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Objective Response Rate;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactWanwei Zheng, Jun Hong
Huashan Hospital, Fudan University
Outcome results
None listed