colorectal cancer
Conditions
Interventions
toripalimab+cetuximab: toripalimab+cetuximab
Sponsors
Fudan University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, gender is not limited; 2. RAS/BRAF wild-type, treated recurrent and metastatic colorectal cancer patients; 3. Reached CR or PR after first-line chemotherapy combined with anti-EGFR cetuximab therapy, and progressed or discontinued cetuximab to disease progression within 4 weeks after the last use of cetuximab patient; 4. Received second-line treatment without cetuximab and had confirmed disease progression; 5. The random grouping time is more than 4 months from the last cetuximab administration in the first-line treatment; 6. Before enrollment, the RAS/BRAF mutation status was detected by ctDNA, which was still wild type, and the HER-2 gene was not amplified; 7. Patients with an ECOG score of 0-1 and expected survival >= 3 months, who can cooperate to observe adverse reactions and curative effects; 8. According to iRECIST criteria, there is at least one measurable tumor lesion; 9. Have good organ function: (1) Neutrophils >= 1.5 x 10^9/L; platelets>= 100 x 10^9/L; hemoglobin >= 9 g/dl; serum albumin >= 3 g/dl; (2) Thyroid-stimulating hormone (TSH) = 60 ml/min; (5) International normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the upper limit of normal value, unless the patient is receiving anticoagulant therapy, and the PT value is within the expected therapeutic range of anticoagulant; (6) Activated partial thromboplastin time (aPTT) <= 1.5 times the upper limit of normal value; 10. No serious concomitant diseases that make the survival period less than 5 years; 11. The pregnancy test of female subjects is negative (for female patients with fertility); female patients without fertility; 12. Male patients with fertility and female patients with fertility and pregnancy risk must agree to take adequate contraceptive measures throughout the study period, and the contraception will continue until 12 months after receiving this regimen; 13. A signed and dated informed consent form, indicating that the patient has been informed of all relevant aspects of the study; 14. Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests and other research procedures; 15. During the study period, those who are willing to abide by the arrangement cannot participate in any other clinical research related to drugs and medical devices.
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed as other intestinal tumors, such as gastrointestinal stromal tumors; 2. Tumor tissue immunohistochemical detection is dMMR, and PCR or NGS detection is MSI-H patients 3. Previously received PD-1 antibody, PD-L1 antibody or CTLA-4 antibody treatment; 4. Patients with other malignant tumors in the past or at the same time, except for fully treated non-melanoma skin cancer, carcinoma in situ of the cervix and papillary thyroid carcinoma; 5. Active autoimmune disease, autoimmune disease history (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood; 6. Have a history of immunodeficiency, including HIV positive, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 7. Intolerance to cetuxim in the past, such as rash, hypomagnesemia, pulmonary toxicity, etc. that cannot be tolerated after symptomatic treatment; 8. Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones), and a history of non-infectious pneumonia; 9. Patients with active tuberculosis infection found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment; 10. The subject has active hepatitis B (HBV DNA >= 2,000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit of the analytical method) 11. Severe cardiopulmonary and renal dysfunction; 12. Suffering from high blood pressure, which cannot be well controlled by antihypertensive drug treatment (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 13. Has a history of psychotropic substance abuse, alcoholism or drug abuse; 14. Other factors judged by the investigator that may affect the subject's safety or test compliance. Such as serious illness (including mental illness) requiring concomitant treatment, serious laboratory test abnormalities, or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactZhiyu Chen
Fudan University Cancer Hospital
Outcome results
None listed