Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.
All eligible patients from 3 hospitals will be equally randomized between the 2 following treatment groups: Standard treatment group: Camrelizumab 200mg IV every 2 weeks. Experimental group: Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.
Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, China
RECRUITINGThe Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
RECRUITINGBest overall response (BOR)
As determined by the investigator using RECIST 1.1 criteria between patients receiving Camrelizumab and stereotactic body radiotherapy and those receiving Camrelizumab alone. BOR rate is defined as the number of patients randomized to a given arm with a best overall response of complete response (CR) or partial response (PR) of non-irradiated lesions divided by the total number of patients randomized to the given arm. In order to ascertain this endpoint, efforts will be made so that patients will be followed for 96 weeks or until progression of disease (and treatment cessation), whichever comes first. At each time-point, subjects should have CT/MR of neck, chest, abdomen, and pelvis with contrast.
Time frame: Time Frame: 96 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.