At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis of patients, the mortality of patients has not been significantly reduced, so new treatment methods are urgently needed. In recent years, immunotherapy has become a new hotspot in tumor therapy. Compared with traditional treatment, immune checkpoint inhibitors (ICIS) have shown long-term good efficacy and tolerance in clinical trials. However, single drug ICIS has reached a bottleneck for advanced gastrointestinal cancer, with low response rate and poor PFS and OS. With the results of REGONIVO showing good efficacy, the treatment mode of immune combined with small molecule anti angiogenesis drugs has sprung up. The purpose of this study was to analyze the efficacy and safety of in Camrelizumab combination with Apatinib mesylate in advanced gastrointestinal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Camrelizumab ,200mg/㎡,d1,ivgtt,every 21 days as a cycle
Apatinib Mesylate,250mg/㎡,po,d1-5 on/d2 off,every 21 days as a cycle
Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGObjective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Time frame: 24 months
progression-free survival(PFS)
the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)
Time frame: 24 months
Overall Survival(OS)
overall survival time after the beginning of the treatment
Time frame: 24 months
Adverse Events
Adverse events will be evaluated according to NCI CTCAE 4.0
Time frame: 24 months
Disease control rate(DCR)
The rate of cases of remission and stable disease accounts for the total evaluable cases after treatment
Time frame: 24 months
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