Could surgery extend life in advanced stomach cancer after a good response to therapy?
NCT ID NCT07757165
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial asks a key question: for people with advanced metastatic stomach cancer whose tumors shrink significantly after initial medical therapy (called conversion therapy), does adding radical surgery improve their chances of living longer without the disease progressing? The study will compare two approaches: one group receives surgery to remove the primary tumor and any remaining metastatic lesions, while the other group continues with the original medical treatment alone. The main goal is to see whether surgery improves the two-year progression-free survival rate, with secondary goals including overall survival and the rate of complete tumor removal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Surgical radical resection (removal of the primary tumor and metastatic lesions) compared with continuing medical treatment alone
- What this could lead to
- If surgery improves survival, it could change standard care for metastatic gastric cancer patients who respond well to initial therapy, offering a potential path to longer life.
- What could go wrong
- This is a Phase II trial with a modest number of participants, so results may not be definitive. Surgery carries risks, and the benefit over medical therapy alone is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2030
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: 1. 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. 2. Pathological Diagnosis: Gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histological or cytological examination. 3. 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.). 4. Conversion Therapy and Efficacy: 1. 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.). 2. 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). 5. 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. 6. Physical Condition: Eastern Cooperative Oncology Group (ECOG) performance status score (PS) of 0 or 1. 7. Good Organ Function (measured within 14 days before randomization), meeting the following laboratory test value standards: 1. Hematological System: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 100 × 10⁹/L Hemoglobin (Hb) ≥ 90 g/L 2. 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) 3. Renal Function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL/min (Cockcroft-Gault formula) 8. 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. Exclusion Criteria: 1. Pathological type: Other pathological types, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, gastrointestinal stromal tumor (GIST), etc. 2. Treatment and efficacy: 1. During the conversion therapy, disease progression (PD) was confirmed after assessment. 2. Previously received systemic anti-tumor treatment for advanced gastric cancer (except for conversion therapy). 3. Previously received radical radiotherapy for the stomach or metastatic lesions. 3. Surgical contraindications: 1. 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.). 2. 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. 4. Past and coexisting disease history: 1. In the past 5 years, had other active malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, etc. 2. 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. 5. Laboratory test abnormalities: Any serious and uncontrolled laboratory test abnormalities were found. The investigator considered that participating in this study would bring significant risks. 6. Pregnancy and lactation: Pregnant or lactating women. 7. 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.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Cancer Hospital
RECRUITINGShanghai, 200032, China