NCT04190745

Toripalimab Combined With Apatinib Mesylate for the Treatment of Gastric Adenocarcinoma in a Prospective Randomized Multicenter Phase II Clinical Study

Zhejiang Cancer Hospital

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Preclinical studies have shown that Toripalimab and Nivolumab and Pembrolizumab have similar safety but better in vivo efficacy than target monoclonal antibody candidates with different sequence characteristics.In addition, apatinib mesylate is a small-molecule drug that can target VEGFR and is itself a powerful therapeutic drug for gastric cancer, so we designed a clinical trial of apatinib combined with toripalimab monoclonal antibody.The study focused on 12 month OS rate, progression-free survival (PFS), clinical objective response rate (ORR), and drug safety.The study was an open, multicenter, randomized controlled clinical trial with a 1:1 distribution of trial and control groups.It is expected that 58 people will be included in the experimental group and 58 people in the control group.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab+Apatinib mesylate	Toripalimab 240mg, ivgtt, Q3w Apatinib mesylate 250mg PO. QD
DRUG	paclitaxel	paclitaxel 80mg/m2, q3w

Timeline

• Start date: 2019-11-29
• Primary completion: 2023-09-01
• Completion: 2024-06-01
• First posted: 2019-12-09
• Last updated: 2019-12-09

Locations

1 site across 1 country: China