Gastrointestinal tumors
Conditions
Interventions
Colorectal cancer:Tolametini: Fixed dose 9mg (reduced to 6mg if necessary), taken orally, twice daily (administered every other day),
Take it on an empty stomach or with a low-fat diet (the time of ta
for 2 weeks
for one cycle
Cetuximab ß Injection: Patients must receive an antihistamine at least 1 hour before the first infusion of this product
Preventive medication for allergens and corticosteroids. It is recommended that
Tremelimumab: 80mg/kg intravenous infusion on day 1 of each cycle, with 2 weeks as one cycle. It is recommended to infuse each time
Note: The duration exceeds 30-60 minutes.
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18-80 years old (including 18 and 80 years old); 2. ECOG score of 0-1; 3. Histologically confirmed advanced or metastatic colorectal cancer with at least one measurable lesion (investigator according to RECIST1.1 evaluation); 4. Received 2-line standard chemotherapy regimen, and there is imaging evidence of disease progression; for neoadjuvant or adjuvant therapy (chemotherapy or chemoradiotherapy), if the disease occurs during treatment or within 6 months after stopping treatment progress should be considered as first-line treatment (as assessed by the investigator according to RECIST 1.1); or standard treatment has been discontinued due to disease progression patients with intolerance to the case; 5. Expected survival period > 12 weeks; 6. The main organ function and bone marrow function are normal, meeting the following requirements: Hemoglobin >=90g/L; (no blood transfusion within 14 days); Neutrophil absolute count >=1.5×10^9/L; Platelet count >=100×10^9/L; Total bilirubin =50%; QTc male < 450ms, Female < 470ms 7. For patients who have not received anticoagulant therapy, their international normalized ratio (INR) of prothrombin time is <=1.5, and some coagulation factors are normal activated Partial Thromboplastin Time (APTT) <=1.5 times ULN. Patients receiving full-dose or parenteral anticoagulant therapy are required to the dose of anticoagulant drugs should be stable for at least 2 weeks before entering clinical research, and the results of coagulation testing should be within the limits of local treatment; 8. The toxicity from previous treatment has been restored to CTCAE standard <= Grade 1 before enrollment (if there is surgery, the wound has been complete healing); 9. Women of childbearing age must undergo a pregnancy test (serum or urine) within 14 days before enrollment, with negative results, and have not had sexual intercourse since willing to use appropriate contraception during the observation period and for 3 months after the last administration of the study drug, and must be non-lactating; male subjects should be surgically sterilized or agree to be observed during and after the last administration of study medication use appropriate contraception for the next 3 months; 10. The patient voluntarily participates and signs the informed consent form, with good compliance expected and ability to cooperate with the study according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Anti-tumor treatment including radiotherapy, chemotherapy (intravenous), targeted therapy, and immunotherapy within 4 weeks before enrollment, or participation in another interventional clinical trial; Oral chemotherapy drugs or targeted drugs within 2 weeks prior to enrollment; 2. Other malignant tumors that still need to be treated within 30 days before enrollment; 3. Poorly controlled hypertension (persistently elevated systolic blood pressure >=150 mmHg or diastolic blood >=100 mmHg) even with medication) 4. Patients with uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA class II and above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 5. Active bleeding within 3 months; Arterial/venous thrombotic events within 6 months; Presence of hereditary or acquired bleeding (eg, coagulation dysfunction) or thrombophilia; Currently using or recently undergoing (10 days prior to initiation of study treatment) full-dose oral or injectable anticoagulant or thrombolytic agents for therapeutic purposes; Surgery (other than biopsy) or surgical incision not fully healed within 4 weeks prior to the study; Current or recent use (10 days prior to the study) of aspirin (>325 mg/day) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; 6. Use of systemic corticosteroids or other systemic immunosuppressive drugs within 2 weeks prior to treatment. Initiation or anticipated need for immunosuppressive medications during the trial period (inhaled glucocorticoids, physiologic replacement doses of glucocorticoids are allowed); 7. History of immunodeficiency, including positive HIV serotest, other acquired, congenital immunodeficiency diseases, or history of organ transplantation; 8. Active hepatitis B (HBeAg positive and HBV DNA>=500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the lower limit of detection of the analytical method); 9. Severe infections requiring antibiotics, antivirals, or antifungal control; 10. Previous or current neuromuscular diseases associated with elevated CK (e.g., inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolytic syndrome); 11. Within 7 days before the start of treatment, or during the study, those who need to use cytochrome P450 (CYP) enzyme activity, such as strong inducers and inhibitors of CYP2C9 and CYP3A4, are taking drugs with a narrow treatment window metabolized by CYP1A2; 12. Known allergy to any component of this test drug; 13. Prior history of definite neurological or psychiatric disorders, including epilepsy and dementia 14. Known uncontrollable or symptomatic active central nervous system (CNS) metastases as present Clinical signs, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. 15. Patients who are unable to swallow the study drug, with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction and other factors that affect drug intake and absorption; 16. Other conditions that the investigator deems unsuitable 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 |
|---|---|
| Duration of Response;Disease control rate;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYong Gao
Shanghai East Hospital
Outcome results
None listed