NCT04182724

Camrelizumab, Apatinib and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II , Open-label , Investigator-initiated Trail of Camrelizumab (an Anti-PD-1 Inhibitor), Apatinib (VEGFR2 Inhibitor) and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. The first part of the study is the Dose-finding Phase designed to establish the safety of Camrelizumab, Apatinib and Nab-paclitaxel at different dose Levels(125 mg/m2, iv. q2w, 150 mg/m2, iv. q2w, 175 mg/m2, iv. q2w or 200 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses . This study aims to evaluate the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel in the Second-line treatment of advanced Gastric Cancer.

Detailed description

This trial investigated the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab, Apatinib and Nab-paclitaxel	Camrelizumab was administered 200mg iv every 2 weeks, Apatinib was administered 250 mg p.o. qd Nab-paclitaxel was administered 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w

Timeline

• Start date: 2019-11-12
• Primary completion: 2021-05-12
• Completion: 2022-05-12
• First posted: 2019-12-02
• Last updated: 2019-12-03

Locations

1 site across 1 country: China