NCT05438108
Unknown
Phase 2
An Open, Single-arm, Exploratory Study of SBRT Sequential CapeOX Chemotherapy Combined With Bevacizumab and Sintilimab in First-line Treatment of Metastatic Colorectal Cancer
Huazhong University of Science and Technology1 site in 1 country30 target enrollmentStarted: July 1, 2022Last updated:
ConditionsMetastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Overview
Brief Summary
Immune checkpoint inhibitors have a poor effect on MSS colorectal cancer. Studies have shown that SBRT, chemotherapy and anti-vascular therapy can enhance the anti-tumor effect of PD-1 antibody. This is a prospective, single-arm study to explore the efficacy and safety of SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab in treatment with patients with initially unresectable advanced colorectal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- •Age ≥ 18 years, ≤75 years;
- •Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer,metastases cannot be removed;
- •No prior systemic treatment for advanced or metastatic colorectal cancer (including chemical therapy, epidermal growth factor receptor inhibitors such as cetuximab or panizumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies and anti-CTLA-4 antibodies);
- •The interval between adjuvant or neoadjuvant chemotherapy is more than one year;
- •According to the definition of RECIST 1.1, the investigator determined that the patient had at least one measurable disease;
- •At least one lesion is suitable for SBRT according to the evaluation of the researchers;
- •Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be enrolled as long as they meet the following conditions:
- •Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or no exacerbation of symptoms for at least 2 weeks; 3) no glucocorticoid treatment or discontinuation of glucocorticoid treatment within 7 days prior to administration of the first study drug;
- •9.ECOG 0-1;
Exclusion Criteria
- •Prior treatment with anti-PD-L1, anti-PD-L2 drugs, or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137);
- •Symptomatic or high-risk obstruction, bleeding, perforation, pneumonia (including noninfectious pneumonia with prior hormone therapy and pneumonia patients under treatment), etc;
- •Other malignant diseases other than colorectal cancer were diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resected carcinoma in situ);
- •Subject is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- •An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic;
- •Subjects were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to study initial dosing;
- •Active hemoptysis (cough up at least 2.5ml or 1/2 teaspoon blood at a time) within 3 months prior to administration of the drug in the first study;
- •Imaging shows tumor invasion/invasion of large vessels or bleeding tendency as assessed by investigator or radiologist;
- •Had major surgery within 4 weeks prior to administration of the first study drug (except for surgery for biopsy purposes) or expected to have major surgery during the study period;
- •Severe unhealed wounds, ulcers or fractures;
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
AEs
Time Frame: up to 36 months
Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.
Secondary Outcomes
- Progression-free survival (PFS)(up to 18 months)
- Disease control rate (DCR)(up to 12 months)
- Overall survival (OS)(up to 36 months)
Investigators
Xianglin Yuan
professor
Huazhong University of Science and Technology
Study Sites (1)
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