NCT07098104

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4.2 years

First QC Date

July 27, 2025

Last Update Submit

July 27, 2025

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

  • PCR

    Pathological complete response

    2019.11-2023.12

  • TRG

    tumor regression grade

    2019.11-2023.12

Secondary Outcomes (2)

  • OS

    2019.11-2023.12

  • EFS

    2019.11-2023.12

Study Arms (2)

neoadjuvant chemotherapy

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).

Drug: Immunotherapy

neoadjuvant immunochemotherapy

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).

Drug: Immunotherapy

Interventions

ImmunotherapyDRUG

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).

Also known as: sintilimab, tislelizumab, nivolumab
neoadjuvant chemotherapyneoadjuvant immunochemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study screened 10,334 patients diagnosed with gastric/gastroesophageal junction tumors at a tertiary-grade A cancer hospital from November 2019 to December 2023 , identifying 777 who received neoadjuvant therapy, with 291 meeting inclusion criteria for final analysis. The cohort comprised resectable gastric adenocarcinoma patients undergoing neoadjuvant immunochemotherapy (nICT, n=98) or chemotherapy (nCT, n=193) followed by radical surgery (Figure S1), with follow-up through November 2024.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ImmunotherapysintilimabtislelizumabNivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

July 27, 2025

First Posted

August 1, 2025

Study Start

November 1, 2019

Primary Completion

December 31, 2023

Study Completion

May 1, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

CN(1)