NCT04563975

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer

Toripalimab Combined With Docetaxel or Nab-paclitaxel in the Treatment of Advanced Gastric Cancer : a Single-arm, Open Label, Prospective Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The single arm clinical study is to evaluate the efficacy and safety of an anti-PD-1 antibody (Toripalimab) combined with chemotherapy (docetaxel or nab-Paclitaxel) in patients with advanced gastric cancer who failed first-line treatment.

Detailed description

54 patients who meet the inclusion criteria will receive Docetaxel (60-75mg/m2, every 3 weeks) or nab-Paclitaxel （125mg/m2，every 3 weeks）combined with Toripalimab( 240mg,every 3 weeks）for 4-8 cycles until the disease progresses or intolerable toxicity.

Conditions

• Gastric Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab，240mg，d1，Intravenous Infusion，q3w
DRUG	Docetaxel	Docetaxel，60-75mg/m2，d8 and d15，Intravenous Infusion，q3w
DRUG	nab-paclitaxel	nab-paclitaxel，125mg/m2，d1 and d 8，Intravenous Infusion，q3w

Timeline

• Start date: 2020-07-02
• Primary completion: 2022-12-31
• Completion: 2023-05-30
• First posted: 2020-09-25
• Last updated: 2021-03-17

Locations

1 site across 1 country: China