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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Stereotactic body radiation therapy
RadiationStereotactic body radiation therapy (SBRT) is a highly precise form of external beam radiation therapy used to treat tumors in various parts of the body. Enrolled patients will initiate SBRT treatment within 2 weeks after the first course of chemotherapy. Intensity-modulated radiation therapy (IMRT) will be used, with the gross tumor volume (GTV) receiving a dose of 8-12 Gy in 5 fractions, resulting in a total dose of 40-60 Gy. The biologically effective dose (BED) is equivalent to 72-132 Gy. The treatment will be administered from Monday to Friday.
PD-1 Monoclonal Antibody
DrugPD-1 monoclonal antibody is a type of immunotherapy drug designed to treat various cancers by targeting the programmed death receptor-1 (PD-1) pathway.The PD-1 monoclonal antibody used in this study is sintilimab at a dose of 200 mg, administered via intravenous infusion on Day 1. Participants will be considered eligible only if they have completed four or more cycles of PD-1 monoclonal antibody treatment both before and after SBRT.
Chemotherapy
DrugChemotherapy regimens based on fluorouracil (5-FU), such as CAPOX with a 3-week cycle or mFOLFOX6/FOLFIRI/FOLFOXIRI with a 2-week cycle, may be combined with targeted therapy. During chemotherapy or chemoradiotherapy, optimal supportive care will be provided.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: SBRT plus PD-1 Monoclonal AntibodyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
ORR
Objective Response Rate
Time frame
1 yearSecondary outcomes
1
DCR
Disease Control Rate
Time frame
1 year2
pCR
Pathological Complete Response
Time frame
1 year3
1 year PFS
Local Progression-Free Survival of 1 Year
Time frame
1 year4
1 year OS
Overall Survival of 1 Year
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jun Huang
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov