Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Cancers

Outcome Measures

Primary Outcomes (1)

safety and clinical efficacy of robotic radical gastrectomy following neoadjuvant therapy
Early Postoperative Complications: Complications occurring within 30 days post-surgery (number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
30 days after surgery

Secondary Outcomes (5)

Neoadjuvant treatment efficacy
2 weeks after surgery
Postoperative quality of life assessment
30 days after surgery
Long-term complications (31 days to 3 years post-surgery)
3 years post-operative
Pathological response rate
2 weeks after surgery
3-year survival
3 years post-operative

Study Arms (1)

Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy

EXPERIMENTAL

Drug: Pre-operative chemotherapyProcedure: Robotic radical gastrectomy after neoadjuvant therapy

Interventions

Pre-operative chemotherapyDrug

Patients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted).

Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy

Robotic radical gastrectomy after neoadjuvant therapyProcedure

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.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Affiliated Hospital of Nanjing University of Chinese Medicine
Othercollaborator
Jiangsu Cancer Institute & Hospital
Othercollaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical Unviersity

Nanjing, Jiangsu, 210000, China

RECRUITING

Hao XuCONTACT86-2568306505 liuhongda@njmu.edu.cn

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

CONTACT

862568306505 liuhongda@njmu.edu.cn

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

February 13, 2025

First Posted

March 26, 2025

Study Start

November 14, 2024

Actual (reported)

Primary Completion

November 14, 2025

Estimated (date passed)

You may not qualify if:

Patients with a history of (within the past 5 years) or current active malignancies. However, patients with cured localized tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, stage I colorectal cancer, etc., are eligible.
A history of upper abdominal surgery (except for laparoscopic cholecystectomy).
A history of gastric resection, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
Patients requiring surgery for other diseases concurrently.
Emergency surgery performed due to complications of gastric cancer (e.g., bleeding, obstruction, or perforation).
Patients preparing for or with a history of organ or bone marrow transplantation.
Blood transfusion within 2 weeks prior to surgery or a history of bleeding disorders, or any severe bleeding event (grade 3 or above according to CTCAE 4.0) occurring within 4 weeks prior to surgery.
Coagulation disorders or bleeding tendencies (INR \> 1.5 without anticoagulant use); patients receiving anticoagulants or vitamin K antagonists, such as warfarin, heparin, or similar agents. Low-dose warfarin (1 mg oral daily) or low-dose aspirin (≤100 mg daily) may be allowed for preventive purposes, provided the prothrombin time international normalized ratio (INR) is ≤ 1.5.
History of thromboembolic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening. Patients with venous thrombosis caused by prior chemotherapy and deemed healed by the investigator are excluded.
Myocardial infarction, poorly controlled arrhythmias (including QTc interval \> 450 ms for males and \> 470 ms for females) within 6 months prior to surgery. QTc interval should be calculated using the Fridericia formula.
NYHA class III or IV heart failure, or left ventricular ejection fraction (LVEF) \< 50% as per echocardiogram.
Pulmonary dysfunction with FEV1 \< 50% of predicted value.
Urinary protein ≥++ on routine urinalysis, confirmed by 24-hour urinary protein quantification \> 1.0 g.
Clinically symptomatic pleural effusion or ascites requiring clinical intervention.
Human immunodeficiency virus (HIV) infection.
+13 more criteria

Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations