SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in First-line Treatment of mCRC

  • End date
    Jan 31, 2024
  • participants needed
  • sponsor
    Huazhong University of Science and Technology
Updated on 14 July 2022


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.

Condition Metastatic Colorectal Cancer
Treatment SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab
Clinical Study IdentifierNCT05438108
SponsorHuazhong University of Science and Technology
Last Modified on14 July 2022


Yes No Not Sure

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
ECOG 0-1
\. Life expectancy >3 months
\. LVEF ≥50%
Adequate organ function, subject will meet the following laboratory
Absolute value of neutrophil (ANC) ≥1.5x109/L
Platelet ≥90×109/L
Hemoglobin≥ 9 g/dL
Total bilirubin ≤1.5× upper normal value (ULN); Or total bilirubin & GT; ULN but direct bilirubin ≤ ULN
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis)
Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60 mL /min
Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN
Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled
Urinary protein <2 +; If urine protein ≥2+, the 24-hour urine protein quantification must be ≤1g
Women of childbearing age must be willing to use adequate contraception during study
drug therapy

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
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
Current or recent use of aspirin (within 10 days prior to receiving the first study
dose) for 10 consecutive days (> 325 mg/ day) or other non-steroidal anti-inflammatory
drugs known to inhibit platelet function; Current or recent (within 10 days prior to
receiving the first study dose) treatment with a full-dose oral or parenteral
anticoagulant or thrombolysis agent for 10 consecutive days
Hereditary bleeding tendency or coagulopathy
Digestive diseases such as active gastrointestinal ulcer, ulcerative colitis
intestinal obstruction, or other conditions that the investigator determines may cause
gastrointestinal bleeding or perforation
Allogeneic organ transplantation (except corneal transplantation) or allogeneic
hematopoietic stem cell transplantation is known
Known allergy to oxaliplatin, capecitabine, sindilizumab or bevacizumab active
ingredients or excipients
Patients with multiple factors affecting oral medication (such as inability to
swallow, post-gastrointestinal resection, chronic diarrhea and intestinal
Has not fully recovered from toxicity and/or complications associated with any
intervention prior to initiation of treatment (i.e., ≤ grade 1 or baseline, excluding
fatigue or hair loss)
Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody
Untreated active hepatitis B
Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the
detection limit)
Received live vaccine within 30 days prior to initial administration (cycle 1, day 1)
Note: Acceptance of injectable inactivated virus vaccine against seasonal influenza is
permitted within 30 days prior to first administration; Intranasally administered live
attenuated flu vaccines are not allowed
Pregnant or lactating women
Grade II or above peripheral neuropathy according to NCI CTCAE standards
Patients undergoing strong CYP3A4 inducers
The presence of any serious or uncontrollable systemic disease
Any medical history or disease evidence that may interfere with the study results
prevent the subjects from participating fully in the study, abnormal values of
treatment or laboratory tests, or other conditions that the investigator considers
inappropriate for the study because of other potential risks that the investigator
considers inappropriate for the study
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