Combining chemotherapy, radiotherapy, and immunotherapy for colorectal cancer liver metastases
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence: A Randomized Controlled Phase II Trial
This study is testing if combining radiation therapy and immunotherapy with chemotherapy can help people who have had surgery for colorectal cancer that has spread to the liver and are at high risk of it coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06120127 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of combining stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in patients with colorectal cancer liver metastases at high risk of recurrence. The study aims to determine if this combination therapy can reduce the risk of recurrence and metastasis compared to chemotherapy alone. By leveraging the local control provided by SBRT and the immune-activating effects of immunotherapy, researchers hope to improve survival outcomes for these patients. The trial will involve patients who have undergone surgical resection of liver metastases and are at risk for recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed colorectal liver metastases who have undergone surgical resection and are at high risk for recurrence.
Not a fit: Patients with uncontrolled epilepsy, serious heart disease, or those who have had other malignancies within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence and improve survival rates for patients with colorectal liver metastases.
How similar studies have performed: While the combination of SBRT and immunotherapy is promising, evidence for its effectiveness in this specific patient population is currently insufficient, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥ 18 years old, female and male 2. pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous) 3. Metastatic liver lesions \<= 5 4. Primary colorectal cancer under control 5. Absence of evidence of extra-hepatic diseases 6. Metastatic liver lesions received resection with insufficient margin (\<0.5cm) or R1/R2 resection 7. Karnofsky \>= 70 8. Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy 9. Without previous antitumoral immunotherapy 10. With good compliance 11. Signed the inform consent Exclusion Criteria: 1. Pregnancy or breast-feeding women 2. History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ) 3. History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders 4. Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months 5. Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents 6. Severe uncontrolled recurrent infections 7. Baseline blood and biochemical indicator do not meet the following criteria: neutrophils \>=1.5×10\^9/L, Hb \>=90g/L, PLT \>=100×10\^9/L, ALT/AST\<=2.5 ULN, Cr \<= 1ULN 8. Allergic to any component of the therapy
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Fan Xia, M.D,PH.D — Fudan University
- Study coordinator: Fan Xia, M.D, PH.D
- Email: tcxiafan@hotmail.com
- Phone: 13564676623
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.