Status:
RECRUITING
Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Microsatellite Stable Metastatic Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 s...
Detailed Description
Control arm: regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle. Experimental arm: regorafenib is administered 80 mg once daily on days 1-21 of each 28 days cycle with intravenou...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Life expectancy of at least 3 months
- Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum
- At least one evaluable metastatic lesion for radiotherapy according to RECIST 1.1
- Progressed on or after the standard first-and second-line therapies or stopped standard therapy because of unacceptable toxic effects
- Previous radiotherapy completed at least 4 weeks before randomization
- Adequate bone-marrow, hepatic, and renal function: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST≤2.5 ULN, Cr≤1 ULN
- Sign the informed consent and have good compliance
Exclusion
- History of previous treatment with regorafenib and ICIs such as anti-PD-1 or anti-PD-L1 mAbs
- Current severe cardiovascular diseases such as unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment
- Active autoimmune diseases and immunodeficiencies, known history of organ transplantation, or systematic use of immunosuppressive agents
- Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: HBsAg positive or HBV DNA positive, anti-HCV antibody testing positive and confirmatory HCV RNA positive
- Positive human immunodeficiency virus (HIV) infection, active syphilis infection, or active pulmonary tuberculosis infection
- Severe infections requiring systemic antibiotics, antifungal or antiviral therapy
- Uncontrollable pleural effusion, pericardial effusion, or ascites
- Other malignancies within 5 years before recruitment, except for non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast cancer in situ that had been effectively treated.
- Known history of severe neurological or mental illness such as schizophrenia, dementia, or epilepsy
- Known history of allergy to any component involved in this study.
- Pregnancy or breast-feeding women
Key Trial Info
Start Date :
April 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 25 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05963490
Start Date
April 25 2023
End Date
April 25 2026
Last Update
September 24 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China