NCT04294784

Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gastric Cancer

A Multi-center, Open-label, Randomized Controlled Clinical Study of Nab-paclitaxel Plus SHR-1210(PD-1 Inhibitor)Versus Nab-paclitaxel As Second-line Treatment in Advanced or Recurrent Gastric and Esophagogastric Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Detailed description

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of an immune checkpoint inhibitor in patients with advanced or recurrent gastric and esophagogastric junction adenocarcinoma, including two arms to compare the efficacy and safety of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）regimen and Albumin-bound Paclitaxel single-agent regimen in second-line treatment.

Conditions

• Gastric Cancer
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)	Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;SHR-1210 200mg, ivdrip,d1,Q21d.
DRUG	Albumin-bound Paclitaxel	Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;

Timeline

• Start date: 2020-04-03
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2020-03-04
• Last updated: 2024-11-04

Locations

1 site across 1 country: China