The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Apatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w
Radiotherapy was administered using IMPT or IMRT. The target volume includes the gastric lesion, and regional lymph nodes. A regimen of 41.4 Gy in 23 fractions is preferred.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGPathological Complete Response
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Total Pathological Complete Response (tpCR)
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Major pathological response(MPR)
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Margin-free (R0) resection rate
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Lymph node status after neoadjuvant therapy (ypN staging)
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
DFS
Time frame: up to 2 years
OS
Time frame: up to 2 years
Local control rate
Time frame: up to 2 years
AEs
Time frame: Up to approximately 18 months
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