Trajectory of Body Composition Identifies LAGC with Cachexia Following NACT

Trajectory of Body Composition Identifies Locally Advanced Gastric Cancer with Cachexia Following Neoadjuvant Chemotherapy (FJMUGS-2411)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06716593

Acronym

FJMUGS-2411

Enrollment

600

Registered

2024-12-04

Start date

2024-09-12

Completion date

2024-11-30

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Gastric Cancer, Trajectory

Keywords

locally advanced gastric cancer, neoadjuvant chemotherapy, cachexia, CT, adjuvant chemotherapy

Brief summary

This longitudinal, multicentre cohort study included LAGC patients treated with NACT between 01/2010-12/2021. BC measurements including skeletal muscle mass (SMM) and total adipose tissue area (TATA) were evaluated by computed tomography at the third lumbar vertebra at baseline and follow-up imaging. Unsupervised latent class growth mixed models were applied to distinguish potential longitudinal SMM and TATA trajectories for identifying cachexia. The primary study endpoint was overall survival (OS), with secondary endpoints including Recurrence-free survival (RFS), objective response rate (ORR) and safety. Multiple Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) for survival.

Detailed description

This is a retrospective, longitudinal, multicenter, real-world cohort study

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

Inclusion criteria

(1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy. \-

Exclusion criteria

(1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data. \-

Design outcomes

Primary

Measure	Time frame	Description
3-year overall survival; 5-year overall survival	3 years or 36 months; 5 years or 60months	Survival status at 3/5 years: survival, death, survival with tumor, deletion.

Countries

China

Outcome results