About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.
Patients with pMMR/MSS colorectal adenocarcinoma;
Age 18-75 years;
Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection/ablation after MDT discussion);
Disqualifiers
Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;
Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);
Unmeasurable liver metastases;
History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
Trial design
Treatments tested in this trial
- Stereotactic body radiation therapy
- PD-1 Monoclonal Antibody
- Chemotherapy
Treatment groups
Sponsors and collaborators
Jun Huang
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor institution