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

To Develop a Prognostic Model for Predicting Survival and Treatment Response for Advanced Gastric Cancer Patients After Neoadjuvant Therapy by Analyzing Hematological Markers Dynamic Load

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06573307
Enrollment
442
Registered
2024-08-27
Start date
2024-06-10
Completion date
2024-08-26
Last updated
2024-08-27

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

Conditions

Gastric Cancer

Keywords

Gastric cancer, Neoadjuvant chemotherapy, inflammation, Oxidative stress, Treatment response, Risk stratification

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.

Interventions

None listed

Sponsors

Chang-Ming Huang, Prof.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
3-year OS3-year OS or 36 monthsOverall survival, death, survival with tumor
3-year DFS3 years DFS or 36 monthsDisease-free survival, death,recurrence
Tumor Regression Grade3 years or 36 monthsa grade system evaluates the pathological response based on the degree of tumor tissue regression after NAT.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026