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Compares treatment options for Locally Advanced Gastric Cancer
Official title Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
ClinicalTrials.gov ID: NCT06597227
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- To be eligible to participate in this study, all patients must meet all the following criteria:
- The people 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...
- Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
You likely can't join if
- To be eligible to participate in this study, all patients must meet all the following criteria:
- The people 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...
- Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
- ECOG score 0-1;
See the full eligibility criteria
Who can join
- To be eligible to participate in this study, all patients must meet all the following criteria:
- The people 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...
- 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 people must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological...
What rules you out
- To be eligible to participate in this study, all patients must meet all the following criteria:
- The people 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...
- 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 people must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.