Comparing two radiotherapy methods for advanced stomach cancer treatment
A Phase II Randomized Trial of Preoperative Hypofractionated Radiotherapy (HFRT) Compared to Personalized Hyperfractionated Stereotactic Adaptive Radiotherapy (PULSAR), Combined with Chemotherapy and PD-1 Monoclonal Antibody for Locally Advanced Gastroesophageal Junction/proximal Gastric Adenocarcinoma
This study is testing whether two different types of radiotherapy combined with chemotherapy and immunotherapy can help people with advanced stomach cancer respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06728657 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a multimodal treatment approach for locally advanced gastric adenocarcinoma and gastro-esophageal junction cancer. Participants will receive either hypofractionated radiotherapy (HFRT) or personalized hyperfractionated stereotactic adaptive radiotherapy (PULSAR), combined with chemotherapy and anti-PD-1 immunotherapy. The study aims to determine which radiotherapy method better enhances the effectiveness of immunotherapy and improves the pathologic complete response (pCR) rate. Surgical resection will be performed for resectable cases, with postoperative treatment tailored by investigators.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed locally advanced gastric adenocarcinoma or gastro-esophageal junction cancer who are potentially resectable.
Not a fit: Patients with peritoneal metastasis, serious medical illnesses, or those who have received prior antitumor therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced stomach cancer.
How similar studies have performed: Other studies have shown promise in using multimodal treatments for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Menglong Zhou, MD
- Email: mrzhouml@163.com
- Phone: 86+18121299608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.