Colorectal Cancer
Conditions
Interventions
Cohort 1:Trastuzumab + Camrelizumab + Irinotecan
Cohort 2:Cetuximab + Pyrotinib + Irinotecan
Cohort 3:Cetuximab + MEK Inhibitor + Irinotecan
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old men and women; 2. ECOG PS 0-1; 3. Advanced colorectal cancer that failed or intolerated standard second-line treatment; 4. Cohort 1: IHC detection showed positive HER2 protein level (IHC: 3+), and confirmed that the RAS gene status was wild type; cohort 2: HER2 gene mutation or amplification was detected by NGS detection, and the wild type RAS gene status was detected and confirmed; cohort 3: BRAF mutation confirmed by NGS test; cohort 4: BRCA1/2 mutation confirmed by NGS test; 5. According to the response evaluation criteria in solid tumor (RECIST 1.1), at least one measurable lesion; 6. Expected survival period >=12 weeks; 7. The main organ function and bone marrow function are normal, meeting the following requirements: (1) Hemoglobin >=90 g/L; (No blood transfusion within 14 days) (2) Absolute neutrophil count =1.5x10^9/L; (3) platelet count >=90x10^9/L; (4) Total bilirubin =50%; QTc male <450ms, female <470ms; 8. Patients who have not received anticoagulant therapy have an international normalized ratio (INR) of <=1.5 and partial thromboplastin time (APTT) <=1.5 times ULN. Patients receiving total or parenteral anticoagulant therapy should be stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; 9. Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment, and voluntarily use the appropriate method for contraception during the observation period and within 3 months after the last administration of the study drug; for men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug. 10. The toxicity of receiving pre-treatment has been restored to <=1 (if the patient received surgery, the wound should be completely healed); 11. Patients voluntarily participate in and sign informed consent, and they are expected to have good compliance and can cooperate with the research according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. Received any kind of anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy, and immunotherapy, or participate in another interventional clinical trial; 2. Major surgery was performed within 4 weeks before enrollment (except for minor surgery, such as placement of vascular access); 3. There is a third interstitial fluid (such as a large amount of pleural effusion or ascites) that has clinical symptoms and cannot be controlled by drainage or other methods; 4. Even after medical treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure >=150mmHg or diastolic blood pressure >=100mmHg); 5. Suffering from uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA II and above heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant patients with supraventricular or ventricular arrhythmia requiring clinical intervention; 6. Severe infection within 2 weeks before the first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5 °C during screening/before first administration; 7. Events of arterial or venous thrombosis occurring within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 8. Have had or have other systemic malignancies in the last 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer); 9. Those who are known to be allergic to any study drug; 10. Pregnant patients, lactating patients, or patients with reproductive ability are not willing to take effective contraceptive measures; 11. Have a clear history of neurological or mental disorders, including epilepsy and dementia; 12. Known uncontrolled or symptomatic active central nervous system (CNS) metastases, manifested by clinical signs, cerebral edema, spinal cord compression, cancerous meningitis, pia mater disease, and/or progressive growth; 13. Patients who are unable to swallow the study drug, such as patients with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), intestinal obstruction, and other various factors that affect drug administration and absorption; 14. Other circumstances that the investigator believes are not suitable for inclusion. If accompanied by family or social factors, it will affect the safety of the subject or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression Free Survival;Overall survival;Vital Signs;Laboratory Index;Adverse Event;Serious Adverse Event;Drug-related Adverse Event;Drug-related Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactGao Yong
Shanghai East Hospital
Outcome results
None listed