This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.
This is a single-arm, prospective and exploratory clinical study. Sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. The patients were treated with endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab to evaluate the efficacy and safety of this regimen. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). The secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Endostar+SBRT+Envafolimab Injection
Endostar+SBRT+Envafolimab Injection
Nanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGDCR
The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects
Time frame: 12 months after the last subject participating in
ORR
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Time frame: 12 months after the last subject participating in
PFS
Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
Time frame: 12 months after the last subject participating in
Incidence of Treatment-Emergent Adverse Events
Occurrence and severity of AEs by NCI CTCAE v5.0
Time frame: Up to 2 years
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