A Benefit Population Atlas of nICT Versus nCT for LAGC

Identifying Optimal Responders: A Benefit Population Atlas of Neoadjuvant Immunochemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07098104

Enrollment

291

Registered

2025-08-01

Start date

2019-11-01

Completion date

2025-05-01

Last updated

2025-08-01

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

Conditions

Gastric Cancer

Brief summary

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?

Detailed 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.

Interventions

DRUGImmunotherapy

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). 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).

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
PCR	2019.11-2023.12	Pathological complete response
TRG	2019.11-2023.12	tumor regression grade

Secondary

Measure	Time frame	Description
OS	2019.11-2023.12	overall survival
EFS	2019.11-2023.12	event-free survival

Countries

China

Outcome results

None listed

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