Gastric CancersPhase 2NCT06895447
Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy
A Phase 2 study testing Pre-operative chemotherapy and Robotic radical gastrectomy after neoadjuvant therapy in people with Gastric Cancers, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancers
- What is being tested?
- Pre-operative chemotherapy and Robotic radical gastrectomy after neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 erythropoietin use within the past 14 days.
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN); if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN, inclusion is permitted.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min.
- Coagulation function defined by international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
- Normal thyroid function, defined by thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, patients with normal total T3 (or FT3) and FT4 levels may still be eligible.
- Normal range for myocardial enzyme profile (patients with isolated laboratory abnormalities deemed clinically insignificant by the investigator may still be included).
- Thyroid function tests (TSH, FT3/FT4) within normal limits or with minor clinically insignificant abnormalities.
- Weight ≥ 40 kg (inclusive) or BMI > 18.5.
- The participant has read, understood, and signed the informed consent form.
Who cannot join
- 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.
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- 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.
- Active pulmonary tuberculosis.
- Chronic non-healing wounds or fractures with incomplete healing.
- History of interstitial lung disease, pneumoconiosis, radiation-induced pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction that may interfere with the detection or management of potential drug-related pulmonary toxicity.
- Known active or suspected autoimmune diseases, except those in stable condition at enrollment and without the need for systemic immunosuppressive therapy.
- Severe chronic autoimmune diseases, such as systemic lupus erythematosus, inflammatory bowel diseases (e.g., ulcerative colitis, Crohn's disease), chronic diarrhea syndromes (e.g., irritable bowel syndrome), sarcoidosis, or tuberculosis. Active hepatitis B or C or HIV infections. Non-severe autoimmune conditions, such as controlled psoriasis, dermatitis, or arthritis, are eligible. Patients with hepatitis B virus (HBV) with a viral load < 500 copies/ml may be included.
- Patients who require systemic corticosteroid treatment (> 10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to surgery or during the study period. However, the following are allowed for inclusion: patients without active autoimmune diseases may use topical or inhaled steroids or adrenal hormone replacement therapy with a dose ≤ 10 mg/day prednisone equivalent.
- Patients who have an active infection requiring systemic antibiotic treatment within 14 days prior to surgery (excluding those receiving prophylactic antibiotics for conditions like urinary tract infections or chronic obstructive pulmonary disease).
- Patients who have received live vaccines within 28 days prior to surgery; seasonal influenza vaccination with inactivated viral vaccines is excluded.
- Patients currently enrolled in another clinical trial involving surgery-related treatments.
- Patients with a history of alcoholism, drug abuse, or substance misuse. Patients who have stopped drinking alcohol are eligible.
- Patients who do not comply with medical instructions, fail to follow prescribed medication regimens, or have incomplete data that could impact the assessment of efficacy or safety.
- Pregnant or breastfeeding female patients.
- Patients with conditions that may increase the risks of participating in the study or with other severe, acute, or chronic diseases deemed by the investigator to be unsuitable for participation.
- Other situations determined by the investigator that make the patient unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, 210000
Hao Xu, 86-2568306505, liuhongda@njmu.edu.cn
About this study
Official title: Efficacy and Safety of Robotic Radical Gastrectomy in Patients With Locally Advanced Gastric Cancer After Neoadjuvant Therapy
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).
- Conditions
- Gastric Cancers
- Being tested
- Pre-operative chemotherapy, Robotic radical gastrectomy after neoadjuvant therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative chemotherapyDrug
Patients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted).
Robotic radical gastrectomy after neoadjuvant therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy | Experimental | Not described Receives: Drug: Pre-operative chemotherapy; Procedure: Robotic radical gastrectomy after neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days after surgery
Secondary outcomes (5)
Neoadjuvant treatment efficacy
R0 resection rate after neoadjuvant therapy
Measured: 2 weeks after surgery
Postoperative quality of life assessment
Postoperative quality of life assessment (Physicians Global Assessment)
Measured: 30 days after surgery
Long-term complications (31 days to 3 years post-surgery)
Long-term complications (31 days to 3 years post-surgery)
Measured: 3 years post-operative
Pathological response rate
Include pathological complete response (pCR) rate, major pathological response (MPR) rate after neoadjuvant therapy, tumor regression grade (TRG) after neoadjuvant therapy, clinical downstaging rate (T and/or N downstaging) after neoadjuvant therapy, objective response rate (ORR) and disease control rate (DCR) after neoadjuvant therapy (RECIST v1.1)
Measured: 2 weeks after surgery
3-year survival
3-year disease-free survival (DFS) rate 3-year overall survival (OS) rate Patterns of recurrence
Measured: 3 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start14 Nov 2024
- Primary completion14 Nov 2025 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancersStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895447
- Sponsor's protocol ID
- RRG-NAT-LAGC
- Status last verified
- Jun 2025
- First submitted
- 13 Feb 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Robotic Radical Gastrectomy in Patients With Locally Advanced Gastric Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06895447
- Acronym / sponsor ID
- RRG-NAT-LAGC
- Conditions
- Gastric Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy | Experimental | Drug: Pre-operative chemotherapy, Procedure: Robotic radical gastrectomy after neoadjuvant therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative chemotherapyPatients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted). | Drug | Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy |
| Robotic radical gastrectomy after neoadjuvant therapyEligible 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. | Procedure or surgery | Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy |
Primary outcome
safety and clinical efficacy of robotic radical gastrectomy following neoadjuvant therapy
Time frame: 30 days after surgery
Early Postoperative Complications: Complications occurring within 30 days post-surgery (number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
5 secondary outcomes
Neoadjuvant treatment efficacy
Time frame: 2 weeks after surgery
Postoperative quality of life assessment
Time frame: 30 days after surgery
Long-term complications (31 days to 3 years post-surgery)
Time frame: 3 years post-operative
Pathological response rate
Time frame: 2 weeks after surgery
3-year survival
Time frame: 3 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pre-operative chemotherapy and Robotic radical gastrectomy after neoadjuvant therapy in people with Gastric Cancers, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu (862568306505, liuhongda@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and clinical efficacy of robotic radical gastrectomy following neoadjuvant therapy (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.