NCT05610332

Clinical Efficacy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes

Clinical Efficacy of Albumin Paclitaxel Plus Carrelizumab Versus FLOT in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes--A Multi-center, Randomised, Open, Phase 3 Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical efficacy of albumin paclitaxel combined with carelizumab and FLOT in the neoadjuvant treatment of locally advanced gastric cancer with different immune types

Detailed description

Background: At present, there is still a lack of prospective data to systematically compare the clinical efficacy of different neoadjuvant therapies in patients with different genotypes. To explore the clinical efficacy and safety of albumin paclitaxel combined with carrelizumab compared with FLOT neoadjuvant therapy in patients with locally advanced gastric cancer of different immune types. Methods: This study is a multi center prospective study. 216 patients with gastric adenocarcinoma were included in the study to explore the proportion of PD-L1 positive cells in tumor tissue, evaluate the expression of PD-L1, serum HBV DNA level or other biomarkers.

Conditions

• Locally Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.
DRUG	Albumin Taxol	Albumin paclitaxel was administered intravenously (without pretreatment) for 30 min on the first day of each cycle
DRUG	FLOT scheme	Docetaxel 50mg/m2, ivgtt, d1; Oxaliplatin 85 mg/m2, ivgtt, d1; Calcium folinate 200mg/m2, ivgtt, d1; 5-fluorouracil 2600mg/m2, 24h civ, d1, 4 cycles before and after operation, q2w

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-01
• Completion: 2027-11-01
• First posted: 2022-11-09
• Last updated: 2022-11-09

Locations

2 sites across 1 country: China