SuspendedPhase 2

Preoperative HFRT Verses PULSAR for Locally Advanced GEJ or Proximal Gastric Adenocarcinoma

Stopped: Difficult in recruiting participants

China68 participantsStarted 2024-07-01

Plain-language summary

The goal of this clinical trial is to evaluate the efficacy and safety of the multimodal treatment, which includes radiotherapy, chemotherapy and anti-PD-1 immunotherapy. The trial is designed using a pick-the-winner strategy. The main questions it aims to answer are: 1. If the multimodal treatment will improve the pCR rate. 2. If the multimodal treatment can be performed safely. 3. Hypofractionated radiotherapy (HFRT) or personalized hyperfractionated stereotactic adaptive radiotherapy (PULSAR), which pattern of radiotherapy can better synergize with immunotherapy. Participants will receive HFRT or PULSAR for the primary lesion and positive lymph nodes, combined with CAPOX and anti-PD-1 immunotherapy. Then, reassessment will be performed within 4 weeks afterwards. For resectable participants, surgical resections will be performed. Postoperative treatment will be determined by the investigators. For unresectable or inoperable participants, the subsequent treatment will be determined by investigators or MDT.

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: * Histopathologically confirmed adenocarcinoma of proximal stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I). * Potentially resectable, cT3-4aN+M0 or cT4bNanyM0. * Exclusion of peritoneal metastasis through laparoscopic exploration or FAPI PET/CT. * The status of HER2, MMR, EBER is clear. * Male or female. Patient age ≥ 18 years and ≤ 75 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. * Physical state or organ function can tolerate the planned treatment of the study protocol. * No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered. * Patients agree to sign written informed consent before recruitment. Exclusion Criteria: * Pregnancy or breastfeeding women. * History of other malignancies within 5 years. * Serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. * Immunodeficiency disease or long-term using of immunosuppressive agents. * Allergic to any component of the therapy. * Any other condition or disease that is not suitable to take the therapy included in the protocol.

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

Pathological complete regression (pCR) rate

Timeframe: 6 months after the enrollment of the last subject

Trial details

NCT IDNCT06728657

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Stomach Adenocarcinoma trials