Actively Recruiting
Efficacy and Safety of Combined With Immunotherapy After Induction Therapy With Chemotherapy and Targeted Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer
Led by yue junhan · Updated on 2023-12-27
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to explore the feasibility of a new mode of chemotherapy and bevacizumab induction therapy combined with immunotherapy as first-line treatment for patients with initially unresectable metastatic colorectal cancer (MSS). The main questions it aims to answer are: 1. To explore the efficacy and safety of this treatment mode 2. Try to study treatment benefit the characteristics of the crowd Participants will combined with immunotherapy after chemotherapy and bevacizumab induction therapy.
CONDITIONS
Official Title
Efficacy and Safety of Combined With Immunotherapy After Induction Therapy With Chemotherapy and Targeted Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participated in the study signed the informed consent and had good compliance
- Body weight 540kg
- 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 512 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)
You will not qualify if you...
- 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
- Immunodeficiency was diagnosed within 7 days before the first treatment or received systemic steroid therapy or any other form of immunosuppressive therapy
- 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 6 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
- 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
- If urine routine test showed urinary protein 2+ and 24-hour urinary protein quantitation >1.0g
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Colorectal Surgery, Affiliated Jinhua Hosptial, Zhejiang University
Jinhua, Zhejiang, China, 321000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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