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Completed

NCT Number: NCT07098104

A Benefit Population Atlas of nICT Versus nCT for LAGC

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?

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Immunotherapy

Drug

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).

Other names: sintilimab, tislelizumab, nivolumab

Primary outcomes

  1. PCR

    Time frame: 2019.11-2023.12

    Pathological complete response

  2. TRG

    Time frame: 2019.11-2023.12

    tumor regression grade

Secondary outcomes

  1. OS

    Time frame: 2019.11-2023.12

    overall survival

  2. EFS

    Time frame: 2019.11-2023.12

    event-free survival

Sponsors and collaborators

Lead sponsor

Cheng Chen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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