Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
RT: one primary or metastatic focus was selected for hypofractionated radiotherapy/SBRT (5-10 Gy/fx, 3-5 fx) in each round, the target area included only the GTV of the visible tumor lesion, and the GTV was expanded by 5-10 mm to generate the PTV, and the prophylactic lymphatic drainage area could not be irradiated.
Sintilimab 200mg d1 iv q3w
Oxaliplatin130mg/m2 d1 iv;Capecitabine1000mg/m2 d1-d14
Bevacizumab 15mg/kg d1 iv q3w
Bevacizumab 7.5mg/kg d1 iv q3w
Gemcitabine1000mg/m2 d1 d8 iv;Cisplatin 25mg/m2 d1 d8 iv q3w
Zhengjiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGORR
for off-target lesions of radiotherapy
Time frame: ORR will be assessed 2 months after radiotherapy
ORR
irradiated lesion
Time frame: ORR will be assessed 2 months after radiotherapy
adverse effects rate
CTC 4.0
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years ]
Qol
EORTC-C30
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years]
PFS
Rate of 3 year disease free survival
Time frame: From the date of randomization to the date when progress was first recorded,assessed up to 36 months.
OS
Rate of 3 year overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Qol
EQ-5D
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years]
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