NCT06597227

Brief Summary

We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer

Trial Health

77
On Track

Trial Health Score

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

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Mar 2024Dec 2028

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 5, 2024

Last Update Submit

April 22, 2026

Conditions

Locally Advanced Gastric Cancer

Keywords

Locally advanced gastric cancerneoadjuvant chemotherapyimmunotherapyProximal radical gastrectomytotal radical gastrectomy

Outcome Measures

Primary Outcomes (1)

  • 3-year Disease-free survival (DFS)

    DFS is based on RECIST(Response Evaluation Criteria in Solid Tumours) 1.1 as assessed by the investigator and is defined as the time from surgery initiation to the date of first documentation of disease recurrence or death due to any cause

    UP to 3 years after surgery

Secondary Outcomes (6)

  • major pathologic response (MPR)

    an average of 2 to 4 weeks after surgery

  • R0 resection rate

    an average of 2 to 4 weeks after surgery

  • Overall Survival (OS)

    UP to 5 years after surgery

  • Percentage of Participants Who Experience One or More Adverse Events (AEs)

    Up to approximately 36 months

  • nutritional status

    UP to 3 years after surgery

  • +1 more secondary outcomes

Study Arms (2)

Proximal radical gastrectomy group

EXPERIMENTAL

Patients with locally advanced upper gastric cancer were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD (Progressive disease) and SD (Stable disease) patients were replaced with conservative treatment or surgical treatment after MDT (Multi-disciplinary Treatment) discussion; (2) For PR (Partial response) and CCR (Clinical complete response) patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, which were divided into experimental group : the group of proximal gastric radical surgery; Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year.

Procedure: Proximal radical gastrectomy

Total radical gastrectomy group

ACTIVE COMPARATOR

Patients with untreated, operable locally advanced upper gastric cancer who signed informed consent and met the screening criteria were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD and SD patients were replaced with conservative treatment or surgical treatment after MDT discussion; (2) For PR and CCR patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, Cohort 2 (control group) : total radical gastrectomy group. Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year.

Procedure: Total radical gastrectomy

Interventions

Proximal radical gastrectomyPROCEDURE

Proximal radical gastrectomy : Dissection of lymph nodes No.1,2,3a,4sa,4sb,7,8a, 9, 11p, 11dare recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: double channel anastomosis is recommended, and other anastomosis methods can be carried out according to the surgeon\'s habit.

Proximal radical gastrectomy group
Total radical gastrectomyPROCEDURE

total radical gastrectomy : Dissection of lymph nodes No.1-7, 8a, 9, 11p, 11d, 12a are recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: Roux⁃en⁃Y anastomosis is recommended

Total radical gastrectomy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible to participate in this study, all patients must meet all the following criteria:
  • The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
  • Age 18-75 years old (at the time of signing the informed consent), both male and female;
  • Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;
  • Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
  • ECOG score 0-1;
  • Expected survival ≥6 months;
  • Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
  • The major organs function well and meet the following criteria:
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  • Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;
  • Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;
  • Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
  • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
  • Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.

You may not qualify if:

  • To be eligible to participate in this study, all patients must meet all the following criteria:
  • The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
  • Age 18-75 years old (at the time of signing the informed consent), both male and female;
  • Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;
  • Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
  • ECOG score 0-1;
  • Expected survival ≥6 months;
  • Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
  • The major organs function well and meet the following criteria:
  • <!-- -->
  • Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;
  • Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;
  • Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
  • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
  • Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Guihua Wang

CONTACT

+86-027-83665215ghwang@tjh.tjmu.edu.cn

lisheng chen

CONTACT

+86-13797056427clsmail1990@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
partial data will be shared 3 years after the study was completed and end in 5 years.
Access Criteria
A shared data acquisition scheme approved by the researcher

Locations

CN(1)