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NOT YET RECRUITING
NCT06684158
PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-11-30

Completion Date

2027-12-01

Last Updated

2024-11-12

Healthy Volunteers

No

Conditions

Interventions

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)

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China