NCT06684158

Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC

Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC: A Prospective, Randomized, Multicenter, Phase 2 Study.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized ，multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The purpose of this study is to assess the safety and efficacy of Mecapegfilgrastim Combined With Adebrelimab and 5- fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)） as Neoadjuvant Therapy in Resectable gastric and gastroesophageal junction cancer

Detailed description

After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomly divided into trial group A and trial group B: Trial group A receive the combination therapy of Mecapegfilgrastim combined with Adebrelimab and FLOT, and trial group B receive the combination therapy of Adebrelimab combined with FLOT, two weeks a cycle, surgery was performed after 4 cycles.

Conditions

• GC/GEJC

Interventions

Type	Name	Description
DRUG	Mecapegfilgrastim	6 mg,HD d3,every 2weeks (Q2W)
DRUG	Adebrelimab	Adebrelimab：1200 mg，iv d1，every2 weeks (Q2W)
DRUG	Docetaxel	Docetaxel：50 mg/m2 iv gtt d1，every 2 weeks (Q2W)
DRUG	Oxaliplatin	Oxaliplatin ：85 mg/m2 iv gtt d1，every2 weeks (Q2W)
DRUG	5-Fluorouracil (5-FU)	5-FU ：2600 mg/m2 ，intravenous infusion， 24h ，d1，every 2 weeks (Q2W)
DRUG	Leucovorin (LV)	LV：200 mg/m2 iv gtt d1，every 2 weeks (Q2W)

Timeline

• Start date: 2024-11-30
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China