NCT07429318

Brief Summary

This study is a single-center, retrospective cohort study. The purpose is to evaluate different perioperative treatment options on the efficacy and survival prognosis of locally advanced GC/GEJC, clarify whether the tumor regression grade can influence survival of patients using neoadjuvant therapy. Moreover, we aim to explore the clinical and pathological characteristics that will affect the long-term survival benefit of patients who underwent perioperative treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress59%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 24, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 28, 2026

Last Update Submit

February 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • OS

    overall survival

    From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented death from any cause, assessed up to 100 months.

Secondary Outcomes (2)

  • EFS

    From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 100 months.

  • DFS

    From the start date of cycle 1 (each cycle is 14 days or 21 days) adjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Study Arms (2)

chemotherapy

patients who only used chemotherapy during neoadjuvant treatment

Procedure: Chemo only

immunochemotherapy

patients who used immunotherapy combined with chemotherapy during neoadjuvant treatment

Procedure: Immunochemotherapy

Interventions

Chemo onlyPROCEDURE

Patients who only used chemotherapy during neodajuvant treatment period

Also known as: chemothreapy
chemotherapy

Patients who used immunotherapy combined with chemotherapy during neodajuvant treatment period

Also known as: immunotherapy combined with chemotherapy
immunochemotherapy

Eligibility Criteria

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

patients who had locally advanced GC/GEJC

You may qualify if:

  • (1) Pathologically diagnosed as gastric adenocarcinoma or esophageal-gastric junction adenocarcinoma, and has not received any anti-tumor treatment before (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)
  • (2) cT3-4N+M0 (according to AJCC version 8 stage) confirmed as resectable by CT or MRI.
  • (3) Patients who underwent adjuvant therapy before surgery.
  • (4) After neoadjuvant therapy , radical resection was performed at the Cancer Hospital of the Chinese Academy of Medical Sciences.
  • (5) Patients who have complete clinical, pathological and imaging data.

You may not qualify if:

  • (1) It is known that peritoneal metastasis or peritoneal irrigation solution cytology is positive (CY1P0) or there is distant metastasis (according to the 8th edition of AJCC).
  • (2) There are unresectable factors, including irresectable tumor causes or surgical contraindications that are irresectable or refuse surgery.
  • (3) Those who have suffered from other malignant tumors within 5 years or at the same time, except for cured skin basal cell carcinoma and cervical cancer in situ and breast cancer in situ.
  • (4) Those who have had radiotherapy, interventional treatment and other local therapists before surgery.
  • (5) Patients whose key diagnosis and treatment information records were missing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 24, 2026

Study Start

January 1, 2026

Primary Completion

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 24, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations