The Necessity of Surgery in Patients With mGC Achieving Radiological Response After Conversion Th… (NCT07757165) | Clinical Trial Compass
RecruitingPhase 2
The Necessity of Surgery in Patients With mGC Achieving Radiological Response After Conversion Therapy
China126 participantsStarted 2025-11-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
2-year PFS
Timeframe: 2 year
Trial details
NCT IDNCT07757165
SponsorFudan University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-10-30
Contact for this trial
Xu Dazhi Director of Gastric Surgery Department, Doctoral candidate
. 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).
. 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.
Exclusion criteria
. 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:
. 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: