计划状态
招聘阶段
第二阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
Camrelizumab标签
MSS/ MMRp评论
Trial in China, only for patients who are about to receive first-line treatment for initially unresectable metastatic colorectal cancer.
The patients will receive camrelizumab in addition to the standard of care (Folfiri and bevacizumab).
camrelizumab: Rivoceranib, Anti PD-, immunotherapy.
No prior Folfiri or fruquintinib allowed.
地点 | 位置状态 |
---|---|
中国 | |
Department of Colorectal Surgery, Affiliated Jinhua Hosptial, Zhejiang University Jinhua, Zhejiang 321000 |
招聘 |
纳入标准
纳入标准
Patients voluntarily participated in the study signed the informed consent and had good compliance
Body weight ≥40kg
Metastatic colorectal cancer confirmed by histology and/or cytology and initially unresectable
Microsatellite instable (MSS) or proficient Mismatch Repair (pMMR)
Patients have at least one measurable lesion (RECIST 1.1)
Eastern Cooperative Oncology Group Physical Status (ECOG PS) 0-1
Expected survival ≥12 weeks
Blood testing (not corrected with granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 7 days prior to laboratory testing if not transfused within 14 days)
Women of reproductive age had to have a serum pregnancy test with a negative result within 14 days before treatment and be willing to use a medically approved effective contraceptive during the study and for 3 months after the last dose of study medication
Age 18-75 years old (including 18 and 75 years old)
排除标准
排除标准:
The patient had received radiation therapy surgery chemotherapy immune or molecular-targeted therapy or other investigational drugs within 4 weeks before treatment
An active autoimmune disease requiring systemic therapy (i.e., disease-modifying medications, corticosteroids, or immunosuppressive agents) had occurred within the previous 2 years. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency, are not considered systemic treatments
Immunodeficiency was diagnosed within 7 days before the first treatment or received systemic steroid therapy or any other form of immunosuppressive therapy. Physiological doses of corticosteroids could be approved after consultation with the sponsor
She had previously received anti-vascular small molecule targeted drug therapy, such as Fruquintinib
Prior treatment with an irinotecan-based chemotherapy regimen
Symptomatic brain or meningeal metastases
Left colon cancer with wild-type rat sarcoma virus gene (RAS)
MSI-H or dificient Mismatch Repair (dMMR) metastatic colorectal cancer
Serious infection (e.g., intravenous antibiotic, antifungal, or antiviral) within 4 weeks before treatment, or unexplained fever > 38.5 ° C during screening/first dose
Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
The patient had obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) may be required
At the time of screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, which were judged by the investigator to have a high risk of bleeding
"Active heart disease, including myocardial infarction, severe/unstable angina, occurred 6 months before treatment." Echocardiography showed that the left ventricular ejection fraction was less than 50% and the arrhythmia was not well controlled
Patients with other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years or at the same time
Known allergy to the study drug or any of its excipients
Severe, active or uncontrolled infection
Any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality, a disease or condition for which there is reason to suspect that the patient is not suitable for use of the study drug (e.g., having seizures requiring treatment), or a condition that would affect interpretation of the study results, or that would place the patient at high risk, in the investigator's judgment
If urine routine test showed urinary protein ≥2+ and 24-hour urinary protein quantitation >1.0g