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Gastric CancerNCT07056010

Efficacy and Safety of Minimally Invasive D2+PAND Gastrectomy for Gastric Cancer With PAN Metastasis After Conversion Immunochemotherapy

A study testing curative minimally invasive gastrectomy with D2+PAND lymphadenectomy in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, open-label, single-center, Phase II clinical trial. Thirty patients with HER2-negative gastric adenocarcinoma or gastroesophageal junction (GEJ) cancer, presenting with PAN metastasis (No. 16 lymph nodes ≥10 mm), will be enrolled. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
curative minimally invasive gastrectomy with D2+PAND lymphadenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
25 Nov 2024to 25 Nov 2028
Phase
Interventional
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 IV （ para-aortic lymph node enlargement without other distant metastatic factors）, suitable for curative R0 resection, as determined by an evaluation by a gastrointestinal surgeon and a radiologic technician prior to enrollment. The patient consented to conversion therapy followed by radical surgical resection, with no surgical contraindications confirmed by the attending surgeon.
  • No. 16 lymph nodes ≥10 mm
  • Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence >6 months from completion of therapy are permitted;
  • Expected survival of ≥6 months.
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  • 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 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.

XU contact

862568306505

liuhongda@njmu.edu.cn

China1 site, 1 recruiting

  • First Affiliated Hospital of Nanjing Medical Unviersity

    Nanjing, Jiangsu, 210000

    Hao Xu, 86-2568306505, liuhongda@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Minimally-invasive Curative Gastrectomy and D2+PAND Lymphadenectomy for Gastric Cancer Patients With Para-aortic Lymph Node (PAN) Metastasis After Conversion Immunochemotherapy

This is a prospective, open-label, single-center, Phase II clinical trial. Thirty patients with HER2-negative gastric adenocarcinoma or gastroesophageal junction (GEJ) cancer, presenting with PAN metastasis (No. 16 lymph nodes ≥10 mm), will be enrolled. Participants will receive four cycles of conversion immunochemotherapy with a PD-1 inhibitor (Serplulimab) combined with the SOX chemotherapy regimen (oxaliplatin and S-1). After completion of conversion therapy, patients will undergo curative minimally invasive (laparoscopic or robotic) gastrectomy with D2+PAND lymphadenectomy

Conditions
Gastric Cancer
Being tested
curative minimally invasive gastrectomy with D2+PAND lymphadenectomy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • curative minimally invasive gastrectomy with D2+PAND lymphadenectomyProcedure or surgery

    Thirty patients with HER2-negative gastric adenocarcinoma or gastroesophageal junction (GEJ) cancer, presenting with PAN metastasis (No. 16 lymph nodes ≥10 mm), will be enrolled. Participants will receive four cycles of conversion immunochemotherapy with a PD-1 inhibitor (Serplulimab) combined with the SOX chemotherapy regimen (oxaliplatin and S-1). After completion of conversion therapy, patients will undergo curative minimally invasive (laparoscopic or robotic) gastrectomy with D2+PAND lymphadenectomy.

Study groups in NCT07056010
Study groupRoleWhat they receive
patients will undergo curative minimally invasive gastrectomy with D2+PANDExperimentalNot described
Receives: Procedure: curative minimally invasive gastrectomy with D2+PAND lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative complications within 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)

    Measured: 30 days after surgery

Secondary outcomes (3)

  1. Neoadjuvant treatment efficacy

    R0 resection rate after neoadjuvant therapy

    Measured: 2 weeks after surgery

  2. TRG

    Tumor Regression Grade

    Measured: 2 weeks after surgery

  3. pCR

    pathological Complete Response

    Measured: 2 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2025
  2. Study start25 Nov 2024
  3. Primary completion25 Nov 2025 (estimated)
  4. Study completion25 Nov 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07056010
Sponsor's protocol ID
CICL-D2PAND
Status last verified
Jun 2025
First submitted
29 Jun 2025
Last updated
9 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing curative minimally invasive gastrectomy with D2+PAND lymphadenectomy in people with Gastric Cancer, 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 22 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 9 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.

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?

postoperative complications within 30 days after surgery (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?

On the ClinicalTrials.gov record for NCT07056010.

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 9 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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