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.
This is a prospective, single-arm, phase Ib trial. At least 9 eligible patients will be will be enrolled In this study. Patients will receive LDRT of 10 Gy in 5 fractions, 15 Gy in 5 fractions, 20 Gy in 10 fractions respectively in our three groups on liver metastsis from Day1 (patients with rectal cancer will receive SCRT concurrently), followed by Xelox and Tislelizumab starting from 1 week after the completion of radiation. The primary endpoints are safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
10 Gy in 5 fractions, 15 Gy in 3 fractions, 20 Gy in 10 fractions respectively in three Cohorts from Day1
25 Gy in 5 fractions from Day1
Oxaliplatin: 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.
200mg IV Q3W on day 1 of each cycle.
Army Medical Center
Chongqing, Chongqing Municipality, China
RECRUITINGDaping Hospital, Army Medical University
Chongqing, Chongqing Municipality, China
ACTIVE_NOT_RECRUITINGIncidence 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
Time frame: 3 years
Objective Response Rate (ORR)
Investigator assessed ORR using RECIST v1.1 including the all tumor
Time frame: 2 years
Progression-free survival (PFS)
Defined as the time from initiation of treatment to tumor progression or death from any cause.
Time frame: 2 years
Overall survival (OS)
Defined as the time from initiation of treatment to death from any cause.
Time frame: 3 years
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