Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy (NCT06895447) | Clinical Trial Compass
RecruitingPhase 2
Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy
China40 participantsStarted 2024-11-14
Plain-language summary
This study is a prospective, open-label, single-arm phase II clinical trial designed to evaluate the safety and efficacy of robotic radical gastrectomy in patients with locally advanced gastric adenocarcinoma after undergoing neoadjuvant therapy. Conducted at multiple centers, the study aims to include 40 patients confirmed via histopathological and/or cytological analysis. Eligible participants must have stage III resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma based on imaging studies such as ultrasound endoscopy, CT, or MRI.
Patients will receive 3-4 cycles of neoadjuvant therapy, followed by imaging evaluations to assess the treatment response and determine eligibility for radical D2 gastrectomy. Within 2-6 weeks of the final neoadjuvant treatment cycle, eligible patients will undergo robotic radical gastrectomy. Key outcomes include post-surgical complications, pathological responses (pCR, MPR, TRG), and objective response rates (ORR), alongside disease-free survival (DFS) and overall survival (OS).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Aged 18 to 80 years, regardless of gender.
* Histologically confirmed gastric cancer or gastroesophageal junction (GEJ) cancer that has received neoadjuvant therapy, with pathology confirming it is predominantly adenocarcinoma. For GEJ cancer, only Siewert Type III and Siewert Type II cases that do not require combined thoracotomy are eligible.
* Tumor stage confirmed as cStage III, suitable for curative R0 resection, as determined by an evaluation by a gastrointestinal surgeon and a radiologic technician prior to enrollment. The patient agrees to undergo robotic-assisted radical surgery, and the surgeon judges there are no surgical contraindications.
* Expected survival of ≥6 months.
* Measurable tumor lesions as defined by RECIST v1.1 criteria (see Attachment 1).
* Preoperative ECOG performance status score (see Attachment 2) of 0 or 1.
* Good cardiac function, capable of undergoing a curative resection. If there are clinical indications, patients with underlying ischemic, valvular heart disease, or other serious heart conditions should undergo preoperative assessment by a cardiologist.
* Normal major organ function, with the following laboratory criteria:
* Absolute neutrophil count (ANC) ≥ 1.2 x 10\^9/L in the absence of granulocyte colony-stimulating factor use within the past 14 days.
* Platelet count ≥ 100 x 10\^9/L in the absence of blood transfusion within the past 14 days.
* Hemoglobin \> 8 g/dL in the absence of blood transfusion or erythropo…
What they're measuring
1
safety and clinical efficacy of robotic radical gastrectomy following neoadjuvant therapy
Timeframe: 30 days after surgery
Trial details
NCT IDNCT06895447
SponsorThe First Affiliated Hospital with Nanjing Medical University