Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy (TJHGC01)

April 22, 2026 updated by: Guihua Wang

Comparison of Clinical Efficacy of Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After SOX Combined With Anti-PD-1 Neoadjuvant Therapy：a Prospective, Multi-center, Randomised，Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gastric cancer is one of the most common malignant tumors in China, and its morbidity and mortality rank among the top three for a long time.How to improve the survival rate of patients with advanced gastric cancer is the key to improve the prognosis.At present, neoadjuvant chemotherapy combined with immunosuppressants has a higher pathologic complete response (pCR) rate, reduce the clinical stage of tumors and improve the resection rate of radical surgery.Some studies have suggested that preserving partial gastric lymph nodes may enhance immunotherapy efficacy.Proximal radical gastrectomy versus total radical gastrectomy can reduce the scope of surgical resection and preserve some lymph nodes, which may contribute to long-term survival and improve postoperative quality of life of patients. It is expected to translate the short-term benefit of neoadjuvant immunotherapy into the benefit of patient overall survival (OS) rate.At the same time, our previous studies have shown that the methylation level of PD-L1 K162 can be used as a new indicator to predict the sensitivity of anti-PD -(L)1 immunotherapy, which is expected to be further confirmed in this clinical trial.Therefore, we plan to conduct a comparative study on the effectiveness and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy for locally advanced upper gastric cancer, which is expected to propose new changes in surgical methods for gastric cancer and a new indicator for screening the advantages of gastric cancer immunotherapy in the era of immunotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Huazhong University of Science and Technology
        • Contact:
          • Tongji Hospital, Huazhong University of Science and Technology
          • Phone Number: +86-027-83662640
          • Email: ims@tjh.tjmu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be eligible to participate in this study, all patients must meet all the following criteria:

    1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
    2. Age 18-75 years old (at the time of signing the informed consent), both male and female;
    3. 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;
    4. Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
    5. ECOG score 0-1;
    6. Expected survival ≥6 months;
    7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
    8. The major organs function well and meet the following criteria:
    1. 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;
    2. 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;
    3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
    4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
    5. 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.

Exclusion Criteria:

  • To be eligible to participate in this study, all patients must meet all the following criteria:

    1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
    2. Age 18-75 years old (at the time of signing the informed consent), both male and female;
    3. 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;
    4. Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
    5. ECOG score 0-1;
    6. Expected survival ≥6 months;
    7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;
    8. The major organs function well and meet the following criteria:
    1. 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;
    2. 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;
    3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
    4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
    5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Proximal radical gastrectomy group
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
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.
Active Comparator: Total radical gastrectomy group
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year Disease-free survival (DFS)
Time Frame: UP to 3 years after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
major pathologic response (MPR)
Time Frame: an average of 2 to 4 weeks after surgery
defined as the percentage of residual viable tumour cells in the tumour bed of no more than 10% after neoadjuvant therapy.
an average of 2 to 4 weeks after surgery
R0 resection rate
Time Frame: an average of 2 to 4 weeks after surgery
defined as the absence of tumor cells present at the resection margin under microscope
an average of 2 to 4 weeks after surgery
Overall Survival (OS)
Time Frame: UP to 5 years after surgery
defined as the time from randomization to death due to any cause.
UP to 5 years after surgery
Percentage of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 36 months
An AE is based on NCI-CTC (The National Cancer Institute Common Toxicity Criteria) 5.0 as assessed by the investigator and is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented.
Up to approximately 36 months
nutritional status
Time Frame: UP to 3 years after surgery
Nutrition was assessed with the patient-generated subjective global assessment (PG-SGA).
UP to 3 years after surgery
quality of life,EORTC QLQ-C30
Time Frame: UP to 3 years after surgery
Questionnaire includes EORTC QLQ-C30 (The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30))(version 3),
UP to 3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guihua Wang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changhai Hospital
Xiangya Hospital of Central South University
Fudan University
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
Southwest Hospital, China
Qilu Hospital of Shandong University
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
The Third Xiangya Hospital of Central South University
Sixth Affiliated Hospital, Sun Yat-sen University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai East Hospital
The First Affiliated Hospital of University of South China
First Hospital of China Medical University
General Hospital of Ningxia Medical University
Shanghai Changzheng Hospital
First Affiliated Hospital of Xinjiang Medical University
Southern Medical University, China
Yichang Central People's Hospital
Affiliated Hospital of Qinghai University
Xiangyang Central Hospital
Liaoning Cancer Hospital & Institute
The First Medical Center of Chinese PLA General Hospital
Shanxi Bethune Hospital
Jingzhou Central Hospital
Shandong First Medical University
The First Affilated Hospital of the Medical College, Shihezi University
People's Hospital of Macheng City
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-S029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

partial data will be shared 3 years after the study was completed and end in 5 years.

IPD Sharing Access Criteria

A shared data acquisition scheme approved by the researcher

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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