Hematological Dynamic Scores for Predicting Survival and Treatment Response for Advanced Gastric Cancer After Neoadjuvant Therapy

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT06573307
• Lead Sponsor: Chang-Ming Huang, Prof.

Brief Summary

HMDLS, based on hematological markers, could effectively distinguish the long-term efficacy of AGC patients after NAT. The predictive performance of nomogram-HMDLS was better than ypTNM stage, achieving better prognostic stratification and tumor treatment response prediction.

Detailed Description

In this research, we incorporated a total of 320 patients from the Union Hospital of Fujian Medical University to form the training cohort (TC). Additionally, we included 122 patients from four distinct medical centers to serve as the external validation cohort (EVC). The Hematological Marker Dynamic Load (ΔHMDL) was determined using the following formula: ΔHMDL = (HMDL pre-surgery - HMDL pre-NAT) / HMDL pre-NAT, where HMDL represents the hematological marker levels before surgery and before the initiation of Neoadjuvant Therapy (NAT), respectively.

Employing LASSO regression analysis, we identified the most influential and statistically significant ΔHMDL indicators. These were then utilized to compute the Hematological Marker Dynamic Load Score (HMDLS), defined as: HMDLS = Σ(LASSO coefficient \* ΔHMDL), where the summation encompasses the products of the LASSO-estimated coefficients and the corresponding ΔHMDL values.

Further, leveraging the outcomes of a multivariate COX regression analysis, we integrated clinical parameters with the HMDLS to formulate a predictive model, termed the Nomogram-HMDLS model. The efficacy of this model in terms of predictive accuracy, clinical utility, and calibration was meticulously assessed and confirmed through several metrics, including the concordance index (C-index), Receiver Operating Characteristic (ROC) curve analysis, decision curve analysis (DCA), and calibration curves.

Study Timeline

• Study Start: 2024-06-10
• Status Verified: 2024-08
• Primary Completion: 2024-08-10
• Study Completion: 2024-08-26
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

• (1) AGC with clinical stage T2-4NxM0 (cT2-4NxM0) before NAT, (2) no history of other malignant tumors, distant metastases or invasion of adjacent organs, and (3) patients who underwent radical gastrectomy after receiving NAT.

Exclusion Criteria

• (1) history of upper abdominal surgery (except for the laparoscopic cholecystectomy), (2) history of upper abdominal radiotherapy, (3) emergency surgery, or palliative surgery, (4) continuous use of medications such as anticoagulant, antiplatelet, and leukocyte-boosting drugs that significantly affect hematological markers during therapy, and (5) incomplete clinical and follow-up data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year OS	3-year OS or 36 months	Overall survival, death, survival with tumor
3-year DFS	3 years DFS or 36 months	Disease-free survival, death,recurrence
Tumor Regression Grade	3 years or 36 months	a grade system evaluates the pathological response based on the degree of tumor tissue regression after NAT.

Trial Locations

Locations (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China