Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. While advancements in targeted therapies and immunotherapy have improved treatment efficacy and extended survival, advanced gastric and gastroesophageal junction adenocarcinomas remain incurable. Subgroup analyses indicate that patients with limited metastases, such as liver oligometastasis or retroperitoneal lymph node metastasis, may benefit more from conversion therapy. However, current guidelines do not recommend specific treatment protocols for gastric cancer with limited metastasis. Immunotherapy has shown moderate efficacy in selected patients with advanced gastric adenocarcinoma. Additionally, low-dose radiotherapy (LDRT) may synergistically enhance antitumor responses when combined with immunotherapy. This Phase II trial aims to evaluate the safety and efficacy of combining Adebrelimab, chemotherapy, and LDRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
* Adebrelimab: Given concurrently with chemotherapy, 1200mg by intravenous infusion every three weeks for four cycles. * Chemotherapy: Oxaliplatin 130mg/m² on day 1 + Capecitabine 1000mg/m² bid (XELOX regimen), from day 1 to day 14, repeated every three weeks for four cycles; * Radiotherapy: Unresectable limited metastatic lesions with SBRT; Potentially resectable lesions with low-dose radiotherapy. * Surgery: Performed 3-5 weeks after the completion of conversion therapy.
Jiangsu cancer hospital
Nanjing, Province, China
RECRUITINGTreatment Safety
Treatment-related adverse events will be categorized by severity and relationship to treatment. Descriptive statistics will be used to summarize the frequency and types.
Time frame: From enrollment until the end of treatment, assessed up to 18 months.
R0 Rate
Defined as the proportion of patients who achieve complete resection with no tumor within 1 mm of the resection margins (R0), calculated by dividing the number of patients achieving R0 resection by the total number of evaluable patients.
Time frame: From the completion of conversion therapy until surgery, assessed within 8 weeks.. following treatment completion
Pathologic complete response
Defined as pT0N0M0
Time frame: From the completion of conversion therapy until surgery, assessed within 8 weeks following treatment completion
Progression-Free Survival
Progression will be assessed based on imaging studies and clinical evaluation, using RECIST v1.1 criteria. Data will be summarized using Kaplan-Meier estimates, and hazard ratios will be calculated.
Time frame: From enrollment until tumor progression or death from any cause, whichever occurs first, assessed up to 2 years
Overall Survival
Overall Survival will be assessed using Kaplan-Meier estimates. Median survival and survival rates at specific time points will be reported.
Time frame: From enrollment until death from any cause, assessed up to 3 years.
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