NCT06597227 Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
| NCT ID | NCT06597227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guihua Wang |
| Condition | Locally Advanced Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 404 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 404 participants in total. It began in 2024-03-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06597227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06597227 currently recruiting?
Yes, NCT06597227 is actively recruiting participants. Contact the research team at ghwang@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT06597227 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06597227 clinical trial?
NCT06597227 is sponsored by Guihua Wang. The trial plans to enroll 404 participants.
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