NCT04286711

Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in Advanced Gastric Cancer

Phase I / II Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in the Second-line Treatment of Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the tolerance of albumin paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination.

Detailed description

This is a Single arm, open, phase I / II clinical trial. The study was divided into tolerance observation stage (dose exploration stage) and efficacy expansion stage (dose expansion stage). This study is to evaluate the tolerance of albumin-paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination. The secondary objective was to evaluate the safety and efficacy of albumin- paclitaxel in combination with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Albumin-paclitaxel, Apatinib, Camrelizumab	Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8, Repeat the therapeutic schedule every 3 weeks; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day, Q3W;

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-08-01
• Completion: 2021-06-01
• First posted: 2020-02-27
• Last updated: 2020-02-27

Locations

1 site across 1 country: China