Actively Recruiting
SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases
Led by Jun Huang · Updated on 2025-05-13
24
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.
CONDITIONS
Official Title
SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before study procedures
- Patients with pMMR/MSS colorectal adenocarcinoma
- Age between 18 and 75 years
- Histologically or cytologically confirmed colorectal cancer liver metastasis deemed unresectable by MDT
- Liver metastases measurable by imaging with maximum diameter 64 cm
- No prior radiotherapy to liver metastases, with at least 700 cc liver volume outside treatment area
- Previous hepatectomy or chemotherapy allowed with a 2-week washout period
- Child-Pugh score Class A
- ECOG performance status 0-1
- Blood counts and liver/renal function within normal ranges tested within 15 days before treatment
- No history of other malignancies; not pregnant or breastfeeding; use effective contraception during and 6 months after study
- Life expectancy of at least 6 months
You will not qualify if you...
- Active hepatitis, cirrhosis, or Child-Pugh Class B or C
- Extrahepatic metastases including bone, brain, or 3 unresectable lung metastases
- Unmeasurable liver metastases
- History of severe drug allergies including to platinum agents, 5-FU, LV, or 5-HT3 receptor antagonists
- Participation in other clinical trials within past 4 weeks
- Prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or other checkpoint inhibitors
- Severe electrolyte abnormalities
- Active gastrointestinal diseases or bleeding risks
- Recent arterial thrombosis or deep vein thrombosis; recent bleeding or bleeding tendency
- Pregnant or breastfeeding; unwillingness to use contraception
- Active autoimmune diseases requiring systemic treatment within past 2 years
- Other active malignancies except certain treated or in situ cancers
- Severe cardiac conditions or recent coronary events
- Active infections with fever over 38BA
- Poorly controlled hypercalcemia, hypertension, or diabetes
- Severe pulmonary diseases
- Psychiatric or central nervous system disorders affecting management
- Severe complications like intestinal obstruction or organ insufficiency
- Unresolved CTCAE Grade 2 or higher toxicities from prior treatments except anemia, alopecia, skin pigmentation
- Unstable medical conditions affecting safety or compliance
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510065
Actively Recruiting
Research Team
J
Jun Huang, PhD.
CONTACT
F
Fang He, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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