A Phase Ib/II Trial of Capeox Regimen Combined With Sintilimab and Bevacizumab in First-line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Phase: PHASE1
Conditions: Stomach Neoplasm
Sponsor: West China Hospital

 
 
 
 
Rationale and design of a phase Ib / II trial 
y of capox regimen combined with 
sindilimab and bevacizumab as first-line 
treatment for recurrent or metastatic 
gastric and gastroesophageal junction 
adenocarcinoma 
 
 
 
2022-08-31 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 

  
 
 
1 、 Purpose 
1.1Main purpose: 
 
The appropriate dose of bevacizumab combined therapy was determined by 
stage IB;The main purpose of phase II was the objective response rate (ORR) of 
the experimental group. 
1.2Secondary purpose: 
 
It included progression free survival (PFS), overall survival (OS), disease 
control rate (DCR), duration of remission (DOR), and adverse reactions;QOL and 
safety of the subjects were evaluated.And to explore the relationship between 
biomarkers in tumor tissues and peripheral blood biomarkers and curative effect. 
 
2 、 Research design, methods and steps 
 
 
This is a multicenter, single arm, prospective, open label, randomized phase 
Ib / II clinical trial (Registration Number: chictr220059975).This study was funded 
by the 13th five year plan.In this study, we prospectively enrolled patients with 
unresectable recurrent or metastatic gastric and esophagogastric junction 
adenocarcinoma, both male and female, who received capox regimen combined 

with sindilimab and bevacizumab as the first-line treatment for advanced gastric 
cancer.In phase IB, 3 + 3 dose climbing design was used to explore the dosage 
of bevacizumab in quadruple regimen.The phase II study was designed as study 
B. according to the bevacizumab dose determined in the phase IB study, the 
enrolled patients were treated with four drug combination regimen for 4-6 
cycles. If PD did not occur after evaluation, capecitabine combined with 
sindilimab and bevacizumab maintenance treatment could be given until 
disease progression, intolerable toxicity, new anti-tumor treatment, 
withdrawal of informed consent, loss of follow-up or deathOr other 
investigators determine that treatment should be stopped.