Trial Title:
Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
NCT ID:
NCT06597227
Condition:
Locally Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Locally advanced gastric cancer
neoadjuvant chemotherapy
immunotherapy
Proximal radical gastrectomy
total radical gastrectomy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Proximal radical gastrectomy
Description:
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.
Arm group label:
Proximal radical gastrectomy group
Intervention type:
Procedure
Intervention name:
Total radical gastrectomy
Description:
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
Arm group label:
Total radical gastrectomy group
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
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Tongji Hospital, Huazhong University of Science and Technology
Phone:
+86-027-83662640
Email:
ims@tjh.tjmu.edu.cn
Start date:
March 1, 2024
Completion date:
December 30, 2028
Lead sponsor:
Agency:
Guihua Wang
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Xijing Hospital-Air Force Military Medical University
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
The First affiliated Hospital of Shandong Second Medical University
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
The First Medical Center of Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Qinghai University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Southern Medical University, China
Agency class:
Other
Collaborator:
Agency:
Zhongnan Hospital
Agency class:
Other
Collaborator:
Agency:
Shanxi Bethune Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
The Third Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Jingzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yichang Central People's Hospital
Agency class:
Other
Collaborator:
Agency:
People's Hospital of Macheng City
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of University of South China
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06597227
