Locally Advanced Gastric CancerTJHGC01NCT06597227
Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
A study testing Proximal radical gastrectomy and Total radical gastrectomy in people with Locally Advanced Gastric Cancer, run by Guihua Wang at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- Proximal radical gastrectomy and Total radical gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Tongji Hospital, Huazhong University of Science and Technology, +86-027-83662640, ims@tjh.tjmu.edu.cn
About this study
Official title: 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
Read the 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.
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Proximal radical gastrectomy, Total radical gastrectomy
- Keywords
- Locally advanced gastric cancer, neoadjuvant chemotherapy, immunotherapy, Proximal radical gastrectomy, total radical gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal radical gastrectomyProcedure or surgery
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.
Total radical gastrectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Total radical gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: UP to 3 years after surgery
Secondary outcomes (6)
major pathologic response (MPR)
defined as the percentage of residual viable tumour cells in the tumour bed of no more than 10% after neoadjuvant therapy.
Measured: an average of 2 to 4 weeks after surgery
R0 resection rate
defined as the absence of tumor cells present at the resection margin under microscope
Measured: an average of 2 to 4 weeks after surgery
Overall Survival (OS)
defined as the time from randomization to death due to any cause.
Measured: UP to 5 years after surgery
Percentage of Participants Who Experience One or More Adverse Events (AEs)
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.
Measured: Up to approximately 36 months
nutritional status
Nutrition was assessed with the patient-generated subjective global assessment (PG-SGA).
Measured: UP to 3 years after surgery
quality of life,EORTC QLQ-C30
Questionnaire includes EORTC QLQ-C30 (The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30))(version 3),
Measured: UP to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guihua Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, Shandong First Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Medical Center of Chinese PLA General Hospital, Affiliated Hospital of Qinghai University, Qilu Hospital of Shandong University, Ruijin Hospital, First Affiliated Hospital, Sun Yat-Sen University, Southern Medical University, China, Shanxi Bethune Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Jingzhou Central Hospital, Xiangyang Central Hospital, Yichang Central People's Hospital, The First Affiliated Hospital of University of South China, Guangdong Provincial People's Hospital, People's Hospital of Macheng City, Southwest Hospital, China, Liaoning Cancer Hospital & Institute, RenJi Hospital, Changhai Hospital, The First Affiliated Hospital of Shihezi University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, First Hospital of China Medical University, Shanghai East Hospital, General Hospital of Ningxia Medical University, Shanghai Changzheng Hospital
- Responsible party
- Sponsor-investigator, Guihua Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597227
- Sponsor's protocol ID
- 2024-S029
- Acronym
- TJHGC01
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06597227
- Acronym / sponsor ID
- TJHGC01 / 2024-S029
- Conditions
- Locally Advanced Gastric Cancer
- Keywords
- Locally advanced gastric cancer, neoadjuvant chemotherapy, immunotherapy, Proximal radical gastrectomy, total radical gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Guihua WangUniversity, hospital or other
- Collaborators
- Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, Shandong First Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Medical Center of Chinese PLA General Hospital, Affiliated Hospital of Qinghai University, Qilu Hospital of Shandong University, Ruijin Hospital, First Affiliated Hospital, Sun Yat-Sen University, Southern Medical University, China, Shanxi Bethune Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Jingzhou Central Hospital, Xiangyang Central Hospital, Yichang Central People's Hospital, The First Affiliated Hospital of University of South China, Guangdong Provincial People's Hospital, People's Hospital of Macheng City, Southwest Hospital, China, Liaoning Cancer Hospital & Institute, RenJi Hospital, Changhai Hospital, The First Affiliated Hospital of Shihezi University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, First Hospital of China Medical University, Shanghai East Hospital, General Hospital of Ningxia Medical University, Shanghai Changzheng Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal radical gastrectomy group | Experimental | Procedure: Proximal radical gastrectomyPatients 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. |
| Total radical gastrectomy group | Active comparator | Procedure: Total radical gastrectomyPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- To be eligible to participate in this study, all patients must meet all the following criteria:
- <!-- -->
Key exclusion criteria (15 listed)
- To be eligible to participate in this study, all patients must meet all the following criteria:
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal radical gastrectomyProximal 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. | Procedure or surgery | Proximal radical gastrectomy group |
| Total radical gastrectomytotal 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 | Procedure or surgery | Total radical gastrectomy group |
Primary outcome
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
6 secondary outcomes
major pathologic response (MPR)
Time frame: an average of 2 to 4 weeks after surgery
R0 resection rate
Time frame: an average of 2 to 4 weeks after surgery
Overall Survival (OS)
Time frame: UP to 5 years after surgery
Percentage of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 36 months
nutritional status
Time frame: UP to 3 years after surgery
quality of life,EORTC QLQ-C30
Time frame: UP to 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal radical gastrectomy and Total radical gastrectomy in people with Locally Advanced Gastric Cancer, run by Guihua Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guihua Wang (+86-027-83665215, ghwang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease-free survival (DFS) (time frame: UP to 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.