NCT04140318

Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

Efficacy and Safety of Sintilimab and Nab-paclitaxel in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Patients With Progression After Fluoropyrimidine or Platinum, a Multi-center, Phase II, Single Arm Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.

Conditions

• Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	sintilimab	Sintilimab 200mg, iv, 30-60min, q3w;
DRUG	nab-paclitaxel	Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w

Timeline

• Start date: 2019-11-15
• Primary completion: 2022-08-30
• Completion: 2023-02-01
• First posted: 2019-10-25
• Last updated: 2022-03-11

Locations

1 site across 1 country: China