Colorectal cancer
Conditions
Interventions
Intervention group:Cetuximab Beta, Pucotenlimab, Chemotherapy
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have a full understanding of this study and voluntarily sign the informed consent form; 2. Age 18-75 years old (including 18 and 75 years old); 3. Patients with pathologically confirmed resectable or potentially resectable locally advanced left hemicolon cancer and upper rectal cancer (cT3-T4b, N+M0); 4. Molecular assay showed KRAS/NRAS wild-type; 5. According to RECIST v1. 1 criterion with at least 1 measurable lesion; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 points; BMI>=18; 7. Expected survival time= 12 weeks; 8. Function of vital organs within 14 days prior to enrollment meets the following requirements: Absolute neutrophil count >=1.5×109/L; platelets>=80×109/L; Hemoglobin >=90g/L; Total bilirubin 50ml/min; 9. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period; 10. Good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed as other intestinal tumors, such as gastrointestinal stromal tumors; 2. Molecular detection shows KRAS/NRAS mutations 3. Participated in other drug clinical trials and received at least one drug treatment within 4 weeks prior to enrollment or received other systemic anti-tumor therapy within four weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, immunotherapy, other clinical investigational drugs; 4. Other malignant tumors within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix; 5. Received a live vaccine within 4 weeks prior to enrollment or possibly during the study; 6. Active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment; 7. Previous allogeneic bone marrow transplantation or organ transplantation; 8. Patient has a current disease or condition that affects drug absorption 9. Subjects who are allergic to the study drug or any of its adjuvant preparations; 10. Clinically significant electrolyte abnormalities judged by the investigator; 11. Hypertension that cannot be controlled by medication before enrollment, as defined as: systolic blood pressure >=150 mmHg and/or diastolic blood pressure >=100 mmHg; 12. Active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or active bleeding from unresected tumors before enrollment, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; 13. Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months with simultaneous hematemesis, black fecals, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 14. History of severe cardiovascular and cerebrovascular disease: • Cerebrovascular accident (except for lacunar cerebral infarction, minor ischemia or transient ischemic attack, etc.), myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias (including QTc interval >=450ms for males and >=470 ms for females) within 6 months prior to the first dose of study drug (QTc interval calculated by Fridericia's formula); • New York Heart Association (NYHA) cardiac function class > class II or left ventricular ejection fraction (LVEF) 1×10^4 copies/mL or >2000 IU/ml); Known hepatitis C virus infection (HCV) with positive HCV RNA (>1×10^3 copies/mL), or other hepatitis, cirrhosis]; 16. Known presence of symptomatic central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate in the trial if the subject is stable (no evidence of radiographic progression for at least 4 weeks prior to the first dose of trial treatment), no evidence of new brain metastases or enlargement of existing brain metastases confirmed by repeat imaging examination, and no steroid therapy was not required for at least 14 days prior to the first dose of trial treatment. This exception does not include carcinomatous meningitis, which should be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Objective response rate;Resection with zero margin rate;Response Evaluation Criteria in Solid Tumours;Overall survival rate;Progression free survival;Disease free survival; | — |
Countries
China
Contacts
Public ContactYe Jianxin
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed