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

NCT06684158 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2027-03-01
Completion
2027-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06684158 on ClinicalTrials.gov