A Benefit Population Atlas of nICT Versus nCT for LAGC

Cheng Chen

Status: Completed

Conditions: Gastric Cancer

Treatments: Drug: Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT07098104

KY-2025-066

Details and patient eligibility

About

The purpose of this observational study is to evaluate the impact of different neoadjuvant therapies on patients with locally advanced gastric cancer. The primary question it aims to address is: Which patient populations benefit most from neoadjuvant immunochemotherapy versus neoadjuvant chemotherapy in locally advanced gastric cancer?

Full description

This study aims to: 1. Compare pCR rates and TRG between neoadjuvant chemotherapy (two-drug vs. three-drug) and neoadjuvant immunochemotherapy; 2. Explore efficacy differences across subgroups; 3. Provide evidence-based guidance for individualized neoadjuvant treatment.

Enrollment: 291 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Eligible patients had pathologically confirmed adenocarcinoma, imaging-confirmed resectable LAGC (cT2-4aN0-3M0, AJCC 8th), no distant metastases, and completed protocol-specified neoadjuvant therapy (nICT: PD-1/PD-L1 inhibitors plus two-drug chemotherapy; nCT: two-drug [SOX/XELOX] or three-drug [FLOT/DCF] chemotherapy) with ECOG 0-1.

Exclusion criteria

Exclusion criteria included incomplete neoadjuvant therapy, non-radical surgery, other malignancies, active autoimmune diseases/immunosuppressant use, missing key data, or inadequate follow-up (<3 months without documented events).

Trial design

291 participants in 2 patient groups

neoadjuvant chemotherapy

Description:

The nCT group included two subgroups: nCT2 (SOX/XELOX) and nCT3 (FLOT: docetaxel 50mg/m² + oxaliplatin 85mg/m² + leucovorin 200mg/m² d1 + fluorouracil 2600mg/m² 48h CIV q2w; or DCF: docetaxel 75mg/m² + cisplatin 75mg/m² d1 + fluorouracil 750mg/m² d1-5 q3w).

Treatment:

Drug: Immunotherapy

neoadjuvant immunochemotherapy

Description:

The nICT group received PD-1 inhibitors (sintilimab 200mg, tislelizumab 200mg, or nivolumab 240mg, all iv q3w) combined with two-drug chemotherapy (SOX: oxaliplatin 130mg/m² d1 + S-1 40-60mg bid d1-14; or XELOX: oxaliplatin 130mg/m² d1 + capecitabine 1000mg/m² bid d1-14, both q3w).

Treatment:

Drug: Immunotherapy