Advanced Metastatic Gastric CancerPhase 2ESMGCNCT07757165
The Necessity of Surgery in Patients With mGC Achieving Radiological Response After Conversion Therapy
A Phase 2 study testing Surgical radical resection (primary lesion + metastatic lesion) and Without surgery, continuing with the original medical treatment in people with Advanced Metastatic Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Metastatic Gastric Cancer
- What is being tested?
- Surgical radical resection (primary lesion + metastatic lesion) and Without surgery, continuing with the original medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Oct 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and Informed Consent: The age range is 18 to 75 years (inclusive), and the participant must voluntarily participate in this study and sign the patient informed consent approved by the ethics committee.
- Pathological Diagnosis: Gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histological or cytological examination.
- Disease Staging: Newly diagnosed, unresectable stage IV disease (according to the 8th edition of the AJCC staging system), confirmed by the multidisciplinary team (MDT) of the research center to be unable to undergo radical surgical resection. The types of metastasis include but are not limited to: unresectable distant lymph node metastasis (such as beyond the abdominal aorta trunk, supraclavicular lymph nodes, etc.); distant organ metastasis (such as liver, lungs, peritoneum, ovaries, etc.).
- Conversion Therapy and Efficacy:
- Has received 4-6 cycles of first-line standard conversion therapy. The treatment plan should be based on the latest clinical guidelines and molecular typing (such as fluorouracil/platinum double or triple drug chemotherapy, combined with anti-HER2 treatment (for HER2-positive patients) or immune checkpoint inhibitors (PD-1/PD-L1 inhibitors, such as when CPS ≥ 5 or MSI-H, etc.).
- After conversion therapy, according to the RECIST 1.1 standard, confirmed by the independent imaging assessment committee (IRC) or at least two senior radiologists, the efficacy reaches complete response (CR) or partial response (PR).
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- Surgical Feasibility Assessment: Re-evaluated by the MDT of the research center (must include senior gastrointestinal surgeons, oncologists, and radiologists), it is considered that all known lesions (primary and metastatic lesions) can be technically achieved R0 resection, and the patient is expected to be safely and tolerably able to undergo surgery.
- Physical Condition: Eastern Cooperative Oncology Group (ECOG) performance status score (PS) of 0 or 1.
- Good Organ Function (measured within 14 days before randomization), meeting the following laboratory test value standards:
- Hematological System:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 100 × 10⁹/L Hemoglobin (Hb) ≥ 90 g/L
- Liver Function:
- Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (if liver metastasis, then ≤ 5 × ULN)
- Renal Function:
- Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL/min (Cockcroft-Gault formula)
- Female patients of childbearing age must have a negative serum pregnancy test within 7 days before randomization, and all patients (regardless of gender) must agree to take effective contraceptive measures during the study and within 6 months after treatment.
Who cannot join
- Pathological type: Other pathological types, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, gastrointestinal stromal tumor (GIST), etc.
- Treatment and efficacy:
- During the conversion therapy, disease progression (PD) was confirmed after assessment.
- Previously received systemic anti-tumor treatment for advanced gastric cancer (except for conversion therapy).
- Previously received radical radiotherapy for the stomach or metastatic lesions.
- Surgical contraindications:
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- According to MDT assessment, there are residual lesions that cannot be surgically removed (such as diffuse peritoneal metastasis that cannot achieve satisfactory tumor reduction, extensive liver metastasis that cannot preserve sufficient functional liver tissue, etc.).
- There are severe internal medical comorbidities that significantly affect surgical safety, and the anesthesiology and surgical physicians have evaluated that the surgical risk is extremely high, for example:
- Uncontrolled heart failure (NYHA cardiac function class III-IV), unstable angina or myocardial infarction within 6 months.
- Severe chronic obstructive pulmonary disease (COPD) or other severe respiratory diseases, which are expected to be intolerant to general anesthesia.
- Uncontrollable severe infection.
- Past and coexisting disease history:
- In the past 5 years, had other active malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, etc.
- Had any uncontrolled severe clinical problems (such as severe mental or neurological diseases) that affected the compliance with the protocol or interfered with the interpretation of the research results.
- Laboratory test abnormalities: Any serious and uncontrolled laboratory test abnormalities were found. The investigator considered that participating in this study would bring significant risks.
- Pregnancy and lactation: Pregnant or lactating women.
- Other: Known to have a severe allergic history to any drugs (chemotherapy drugs, targeted drugs, immunotherapies, anesthetics, etc.) used in the study protocol. The investigator believed that there were any other situations that were not suitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xu Dazhi Director of Gastric Surgery Department, Doctoral candidate contact
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, 200032
Weijing Zhang, +86 21 3477 8299
About this study
Official title: Phase II Randomized Controlled Trial Evaluating the Necessity of Surgery in Patients With Advanced Metastatic Gastric Cancer Achieving Radiological Response After Conversion Therapy
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.
Read the detailed description
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.
- Conditions
- Advanced Metastatic Gastric Cancer
- Being tested
- Surgical radical resection (primary lesion + metastatic lesion), Without surgery, continuing with the original medical treatment
- Keywords
- Advanced metastatic gastric cancer, Conversion therapy, Radiological response, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical radical resection (primary lesion + metastatic lesion)Procedure or surgery
Surgical radical resection (primary lesion + metastatic lesion)
Without surgery, continuing with the original medical treatmentDrug
Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| The surgical group | Experimental | Surgical radical resection (primary lesion + metastatic lesion) + postoperative adjuvant therapy Receives: Procedure: Surgical radical resection (primary lesion + metastatic lesion) |
| The non-surgical group | Experimental | Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs. Receives: Drug: Without surgery, continuing with the original medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS
Two-year progression-free survival rate
Measured: 2 year
Secondary outcomes (2)
2-year OS
2 year Overall Survival
Measured: 2 year
The R0 resection rate
The R0 resection rate of surgery group
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Nov 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757165
- Sponsor's protocol ID
- ESMGC
- Acronym
- ESMGC
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.
PubMed 34102137Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PubMed 20728210Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.
PubMed 32861308
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial Evaluating the Necessity of Surgery in Patients With Advanced Metastatic Gastric Cancer Achieving Radiological Response After Conversion Therapy
- ClinicalTrials.gov ID
- NCT07757165
- Acronym / sponsor ID
- ESMGC / ESMGC
- Conditions
- Advanced Metastatic Gastric Cancer
- Keywords
- Advanced metastatic gastric cancer, Conversion therapy, Radiological response, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 11 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The surgical group | Experimental | Procedure: Surgical radical resection (primary lesion + metastatic lesion)Surgical radical resection (primary lesion + metastatic lesion) + postoperative adjuvant therapy |
| The non-surgical group | Experimental | Drug: Without surgery, continuing with the original medical treatmentWithout surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age and Informed Consent: The age range is 18 to 75 years (inclusive), and the participant must voluntarily participate in this study and sign the patient informed consent approved by the ethics committee.
- Pathological Diagnosis: Gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histological or cytological examination.
- Disease Staging: Newly diagnosed, unresectable stage IV disease (according to the 8th edition of the AJCC staging system), confirmed by the multidisciplinary team (MDT) of the research center to be unable to undergo radical surgical resection. The types of metastasis include but are not limited to: unresectable distant lymph node metastasis (such as beyond the abdominal aorta trunk, supraclavicular lymph nodes, etc.); distant organ metastasis (such as liver, lungs, peritoneum, ovaries, etc.).
- Conversion Therapy and Efficacy:
- Surgical Feasibility Assessment: Re-evaluated by the MDT of the research center (must include senior gastrointestinal surgeons, oncologists, and radiologists), it is considered that all known lesions (primary and metastatic lesions) can be technically achieved R0 resection, and the patient is expected to be safely and tolerably able to undergo surgery.
Key exclusion criteria (17 listed)
- Pathological type: Other pathological types, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, gastrointestinal stromal tumor (GIST), etc.
- Treatment and efficacy:
- Surgical contraindications:
- Uncontrolled heart failure (NYHA cardiac function class III-IV), unstable angina or myocardial infarction within 6 months.
- Severe chronic obstructive pulmonary disease (COPD) or other severe respiratory diseases, which are expected to be intolerant to general anesthesia.
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 |
|---|---|---|
| Surgical radical resection (primary lesion + metastatic lesion)Surgical radical resection (primary lesion + metastatic lesion) | Procedure or surgery | The surgical group |
| Without surgery, continuing with the original medical treatmentWithout surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs. | Drug | The non-surgical group |
Primary outcome
2-year PFS
Time frame: 2 year
Two-year progression-free survival rate
2 secondary outcomes
2-year OS
Time frame: 2 year
The R0 resection rate
Time frame: 2 year
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 11 Aug 2026.
- Results publication: PubMed 34102137Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.
- Results publication: PubMed 20728210Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
- Results publication: PubMed 32861308Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.
- Individual participant dataSharing planned: No
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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.
Xu Dazhi Director of Gastric Surgery Department, Doctoral candidate contact
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 Surgical radical resection (primary lesion + metastatic lesion) and Without surgery, continuing with the original medical treatment in people with Advanced Metastatic Gastric Cancer, run by Fudan 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 16 inclusion and 17 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 11 Aug 2026. 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 Dazhi Director of Gastric Surgery Department, Doctoral candidate (+8618121299796, xudzh@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS (time frame: 2 year). 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 NCT07757165, which also lists 3 linked publications.
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 11 Aug 2026.