Regorafenib with radiotherapy and toripalimab for metastatic colorectal cancer
A Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer
This study is testing whether adding a new drug and radiation to regorafenib can help people with advanced colorectal cancer live longer and feel better compared to just taking regorafenib alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | toripalimab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05963490 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of regorafenib alone versus regorafenib combined with hypofractionated radiotherapy and toripalimab in patients with microsatellite stable metastatic colorectal cancer. Participants are randomly assigned to either receive regorafenib alone or a combination of regorafenib and toripalimab followed by radiotherapy. The study aims to analyze survival benefits, response rates, and adverse effects associated with each treatment approach. The treatment regimens involve specific dosing schedules for regorafenib and toripalimab, along with defined radiotherapy protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with microsatellite stable metastatic colorectal cancer who have progressed on standard therapies.
Not a fit: Patients with a history of severe cardiovascular diseases or previous treatment with regorafenib or immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with metastatic colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and radiotherapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years old 2. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1 3. Life expectancy of at least 3 months 4. Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum 5. At least one evaluable metastatic lesion for radiotherapy according to RECIST 1.1 6. Progressed on or after the standard first-and second-line therapies or stopped standard therapy because of unacceptable toxic effects 7. Previous radiotherapy completed at least 4 weeks before randomization 8. 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 9. Sign the informed consent and have good compliance Exclusion Criteria: 1. History of previous treatment with regorafenib and ICIs such as anti-PD-1 or anti-PD-L1 mAbs 2. Current severe cardiovascular diseases such as unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication 3. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment 4. Active autoimmune diseases and immunodeficiencies, known history of organ transplantation, or systematic use of immunosuppressive agents 5. 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 6. Positive human immunodeficiency virus (HIV) infection, active syphilis infection, or active pulmonary tuberculosis infection 7. Severe infections requiring systemic antibiotics, antifungal or antiviral therapy 8. Uncontrollable pleural effusion, pericardial effusion, or ascites 9. 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. 10. Known history of severe neurological or mental illness such as schizophrenia, dementia, or epilepsy 11. Known history of allergy to any component involved in this study. 12. Pregnancy or breast-feeding women
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Zhen Zhang, MD, PHD — Fudan University
- Study coordinator: Zhen Zhang, MD, PHD
- Email: zhen_zhang@fudan.edu.cn
- Phone: 18801735029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.