In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.
Age between18 and 75 years old.
Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
Simultaneous liver metastasis confirmed by imaging examination.
Distant metastasis from other than the liver.
BMI < 18.5 kg/m² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on body weight).
Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational (non-interventional) clinical study; received anti-tumor vaccines or live vaccines.
Active autoimmune diseases, or a history of autoimmune diseases. A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10^4/ml), HCV infection or HCV DNA positive(≥1×10^3/ml) and liver cirrhosis.
Single group
Low Dose Radiotherapy
Radiation10 Gy in 5 fractions, 15 Gy in 3 fractions, 20 Gy in 10 fractions respectively in three Cohorts from Day1
Short course Radiotherapy
Radiation25 Gy in 5 fractions from Day1
XELOX
DrugOxaliplatin: 130mg/m2 IV Q3W on day 1 of each cycle. Capecitabine: 1000mg/m2 Q3W Dose of 1000mg/m2 on day 1-14 of each cycle.
Tislelizumab
Drug200mg IV Q3W on day 1 of each cycle.
Incidence of treatment-emergent adverse events
Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of LDRT in Combination With Tirellizumab and XELOX
Objective Response Rate (ORR)
Investigator assessed ORR using RECIST v1.1 including the all tumor
Progression-free survival (PFS)
Defined as the time from initiation of treatment to tumor progression or death from any cause.
Overall survival (OS)
Defined as the time from initiation of treatment to death from any cause.
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