Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
Recruiting · NCT05963490 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, China