Robots take on tricky stomach tumors: new safety trial launches
NCT ID NCT07405125
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how safe robotic surgery is for removing gastrointestinal stromal tumors (GISTs) located in hard-to-reach areas of the stomach. About 182 adults with small to medium tumors (2-5 cm) will have the robotic procedure. Researchers will track how many patients stay cancer-free for 3 years after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 182 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18 to 75 years, regardless of sex. * Diagnosis of GIST located at a special anatomic site confirmed preoperatively by endoscopy/endoscopic ultrasound, CT, or MRI. * Preoperative imaging suggests a tumor diameter between 2 cm and 5 cm. * No prior neoadjuvant therapy (e.g., imatinib) administered. * Expected survival period ≥ 6 months. * Preoperative assessment indicates feasibility for robotic surgery. * Preoperative examinations show no evidence of distant metastasis or direct invasion into adjacent organs. * Preoperative ECOG Performance Status score of 0 or 1. * Preoperative ASA Physical Status classification of I to III. * The subject has read and fully understood the patient information sheet and provided written informed consent. Exclusion Criteria: * History of previous upper abdominal surgery (except laparoscopic cholecystectomy). * History of previous gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD). * Previous administration of neoadjuvant therapy (e.g., imatinib). * Presence of other active malignancies within the past 5 years or concurrently. (Note: Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, Stage I lung cancer, or Stage I colorectal cancer, may be enrolled.) * Requirement for concurrent surgery for other diseases. * Emergency surgery performed due to tumor-related complications (bleeding, obstruction, or perforation). * Arterial/venous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (excluding thrombosis related to prior chemotherapy venous catheters deemed resolved by the investigator), and pulmonary embolism. * Myocardial infarction within 6 months prior to surgery, or poorly controlled arrhythmia (including QTc interval ≥450 ms for males or ≥470 ms for females, calculated using Fridericia's formula). * Cardiac insufficiency classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \<50% on cardiac ultrasound. * Ventilatory dysfunction: FEV1 \<50% of predicted value. * Clinically symptomatic pleural or abdominal effusion requiring clinical intervention. * Human Immunodeficiency Virus (HIV) infection. * Active pulmonary tuberculosis. * History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function that may interfere with the detection or management of suspected drug-related pulmonary toxicity. * Any active infection requiring systemic anti-infective therapy within 14 days prior to surgery; except for prophylactic antibiotic therapy (e.g., for urinary tract infection or chronic obstructive pulmonary disease). * Concurrent participation in another clinical trial involving surgical treatment. * History of alcohol abuse, drug abuse, or substance abuse. (Note: Patients who have ceased alcohol consumption may be enrolled.) * Patients deemed likely to be non-compliant with medical advice or medication regimens, or with incomplete data that may affect efficacy or safety assessment. * Pregnant or lactating female patients. * Any condition that may increase the risk associated with study participation, or other severe, acute, or chronic diseases, or any other situation that, in the investigator's judgment, makes the patient unsuitable for clinical study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)
RECRUITINGNanjing, Jiangsu, China
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