Actively Recruiting
Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Led by Fudan University · Updated on 2024-09-24
108
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 54 patients will receive regorafenib monotherapy. Experimental arm: a total of 54 patients will first receive 1 cycle of regorafenib and toripalimab followed by hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The survival benefits, response rates, and adverse effects will be analyzed.
CONDITIONS
Official Title
Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months
- Histologically confirmed microsatellite stable or proficient mismatch repair adenocarcinoma of the colon or rectum
- At least one metastatic lesion suitable for radiotherapy evaluation by RECIST 1.1
- Disease progression after or intolerance to standard first- and second-line therapies
- Previous radiotherapy completed at least 4 weeks before enrollment
- Adequate bone marrow, liver, and kidney function: neutrophils 60 1.5 x 10^9/L, hemoglobin 60 90 g/L, platelets 60 100 x 10^9/L, ALT/AST 640.5 times upper limit of normal, creatinine 60 1 times upper limit of normal
- Signed informed consent and good compliance
You will not qualify if you...
- Prior treatment with regorafenib or immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 monoclonal antibodies
- Severe cardiovascular diseases including unstable angina, congestive heart failure, or serious arrhythmia requiring medication
- Acute heart attack or stroke within 6 months before enrollment
- Active autoimmune diseases, immunodeficiency, history of organ transplantation, or use of immunosuppressive agents
- Active hepatitis B or C infection, positive viral markers
- Positive HIV infection, active syphilis, or active pulmonary tuberculosis
- Severe infections needing systemic antibiotics, antifungals, or antivirals
- Uncontrolled pleural, pericardial effusion, or ascites
- Other cancers within 5 years except certain effectively treated skin, bladder, cervical, or breast cancers
- Severe neurological or mental illnesses such as schizophrenia, dementia, or epilepsy
- Allergy to any study components
- Pregnancy or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhen Zhang, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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