SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJun Huang

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

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jun Huang

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution