Actively Recruiting
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC
Led by Huazhong University of Science and Technology · Updated on 2023-12-21
40
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II Study to Assess the Efficacy and Safety of Cadonilimab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer
CONDITIONS
Official Title
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Aged 18 to 75 years
- Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer
- Microsatellite stable (MSS) status
- Have undergone two or more standard systemic therapies including chemotherapy agents such as fluorouracil, oxaliplatin, irinotecan, bevacizumab, and cetuximab, with treatment failure or intolerable toxicities
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Have measurable lesions
- Expected overall survival of at least 12 weeks
- Liver enzymes AST, ALT, and alkaline phosphatase no more than 2.5 times upper limit of normal (ULN); serum bilirubin no more than 1.5 times ULN; creatinine below ULN
- Prothrombin time (PT) and international normalized ratio (INR) no greater than 1.5 times ULN
- If previously received radiotherapy, at least 4 weeks have passed and current radiotherapy lesions are untreated
- Fertile males or females must use effective contraception during the study and for 6 months after last medication
You will not qualify if you...
- Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4 immunotherapy, or other experimental immunotherapies
- Severe autoimmune diseases including active inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or autoimmune vasculitis
- Symptomatic interstitial lung disease or active infection/non-infectious pneumonia
- Risk factors for intestinal perforation such as active diverticulitis, abdominal abscess, or gastrointestinal obstruction
- Recent surgery without complete wound healing
- History of other malignancies except certain cured localized tumors
- Organ or allogeneic bone marrow transplant history or preparation
- Moderate or severe ascites, uncontrolled pleural or pericardial effusion
- Recent gastrointestinal bleeding or high risk for bleeding within 6 months
- Abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Known bleeding or thrombotic disorders or recent therapeutic anticoagulant use
- Use of high-dose antiplatelet agents
- Thrombosis or embolism events within 6 months
- Active infection, heart failure, heart attack, unstable angina or arrhythmia within 6 months
- Conditions increasing risk of treatment complications or interfering with study results
- Emergency need for palliative radiotherapy or surgery
- Pregnant or lactating women
- Immunodeficiency or organ transplantation
- Mental illness or substance abuse affecting compliance
- Active infection including tuberculosis; stable hepatitis B or C allowed
- Live vaccine within 30 days prior to enrollment
- Uncontrolled heart disease or hypertension
- Major vascular disease within 6 months
- Severe wounds, ulcers, or fractures
- Major surgery within 4 weeks prior or planned during study
- Inability to swallow tablets or malabsorption
- History or signs of intestinal obstruction within 6 months
- Abdominal gas accumulation unexplained by procedures
- Metastatic disease affecting major airway or blood vessels
- History of hepatic encephalopathy
- Interstitial lung disease or pneumonia affecting lung function
- Active autoimmune disease or history with possible recurrence except certain controlled conditions
- Recent use of immunosuppressants or systemic hormones
- Severe allergy to monoclonal antibodies or anti-angiogenesis drugs
- Recent severe infection or antibiotic treatment
- Other factors judged by investigator affecting safety or study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
X
Xianglin Yuan
CONTACT
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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