A Phase 2 interventional study of Surgical radical resection (primary lesion + metastatic lesion) and Without surgery, continuing with the original medical treatment in Advanced Metastatic Gastric Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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Among 58 studies in Stomach Neoplasms by Fudan University — 27 open to participants now, 31 under way, 3 of them phase 3. Stomach Neoplasms · Fudan University.
Among the 58 studies in Stomach Neoplasms by Fudan University, this one is the 19th largest by planned enrollment of the 48 interventional ones that give a count, is one of 8 that started in 2025, is one of 32 in phase 2, reaches primary completion later than 22 of the 30 other live ones, and was the 57th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →27 of the 58 studies in Stomach Neoplasms by Fudan University are open now, in 1 country. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18+
Fudan University · Sites in China
Ages 18+
Fudan University · Sites in China
Ages 18–70
Fudan University · Sites in China
Ages 18–80
Fudan University · Sites in China
Ages 40+ · Healthy volunteers
By country, each count listing its studies:
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 34 · Phase 3 10
First in 2000; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 126 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 90 across the 48 interventional studies, 1,800 across the 10 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Fudan University is the lead sponsor of 1,317 studies on the registry; 645 are open to participants now.
5 of the studies in Stomach Neoplasms by Fudan University that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04997837Phase 3Fudan UniversityStudy of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma | 2027-07-21 |
| NCT07400354Fudan UniversityThe Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota | 2027-03-14 |
| NCT06748508Fudan UniversityComparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer | 2027-07-25 |
| NCT07389876Fudan UniversityAlbumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma | 2027-09-01 |
| NCT07312500Fudan UniversityFecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer | 2027-10-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 58 studies in Stomach Neoplasms by Fudan University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The core of this study lies in directly addressing the most pressing clinical uncertainty in the current field: For patients with advanced metastatic gastric cancer who have achieved significant radiological remission after conversion therapy, should the addition of radical surgical intervention on top of the best medical treatment bring clear survival benefits to these patients? Answering this question is of extreme importance and urgency, directly affecting the treatment decisions, quality of life, and survival outcomes of a large number of patients.
The innovation and scientific nature of this study lie in its adoption of a multi-center, randomized controlled Phase II study design for the first time. It directly compares the efficacy differences between "surgery + postoperative adjuvant therapy" and "simple continuation of medical treatment" for this specific population, aiming to eliminate selection bias and confirm the causal relationship. We strictly limited the enrolled population to those with "significant imaging remission and technically resectable at R0 level" by MDT assessment, ensuring the homogeneity of the research subjects and the specificity of the questions. The primary research endpoint was set as progression-free survival (PFS), and secondary endpoints included overall survival (OS), R0 resection rate, quality of life (QoL), and treatment-related toxic side effects, allowing for a comprehensive evaluation.
Carrying out this study has significant scientific and clinical value. Its results will provide Level 1 evidence-based medical evidence for the treatment strategy of this population. If the surgical group shows superiority, it will firmly establish the position of surgery and promote it to become the standard treatment; if the results are negative (equivalence between the two groups or the surgical group is inferior), it will avoid a large number of patients suffering from unnecessary surgical trauma, promoting the treatment model to return to a core of systematic treatment, thereby changing global clinical guidelines. At the same time, the study has important health economics significance, helping to allocate limited medical resources to truly benefit patients. Through exploratory research on biological specimens, it can also deepen the understanding of the biological behavior of advanced gastric cancer and provide clues for more precise patient screening in the future.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Conversion Therapy and Efficacy:
Good Organ Function (measured within 14 days before randomization), meeting the following laboratory test value standards:
Hematological System:
(ANC) ≥ 1.5 × 10⁹/L count (PLT) ≥ 100 × 10⁹/L (Hb) ≥ 90 g/L
Liver Function:
Serum total (TBIL) ≤ 1.5 times the (ULN) (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (if liver metastasis, then ≤ 5 × ULN)
Serum creatinine (Cr) ≤ 1.5 × ULN, or rate (Ccr) ≥ 50 mL/min (Cockcroft-Gault formula)
Exclusion Criteria:
Treatment and efficacy:
Surgical :
Uncontrolled heart failure ( cardiac function class III-IV), unstable angina or myocardial infarction within 6 months.
Severe (COPD) or other severe respiratory diseases, which are expected to be intolerant to general anesthesia.
Uncontrollable severe infection.
Past and coexisting disease history:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical radical resection (primary lesion + metastatic lesion) + postoperative adjuvant therapy
Procedure: Surgical radical resection (primary lesion + metastatic lesion)
Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs.
Drug: Without surgery, continuing with the original medical treatment
Surgical radical resection (primary lesion + metastatic lesion)
Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs.
2-year PFS
Two-year progression-free survival rate
Time frame: 2 year
2-year OS
2 year Overall Survival
Time frame: 2 year
The R0 resection rate
The R0 resection rate of surgery group
Time frame: 2 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Oct 2028, 35 months after the start.
Of 295 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 76. This study's planned 35 months is below that.
Counting every sponsor, half of 360 studies reached it within 50 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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