Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiangsu Cancer Institute & Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET/CT scans, and multidisciplinary team (MDT) discussion.
From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable; limited metastatic lesions are evaluated by MDT for resectability or for the possibility of achieving curative treatment through other local treatment methods (such as local radiotherapy or radiofrequency ablation).
Exclusion of peritoneal metastasis.
Disqualifiers
Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
The primary lesion is considered unresectable from a medical or surgical technical perspective.
Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread metastasis).
Peripheral neuropathy of grade ≥2.
Trial design
Design model
Single group
Treatments tested in this trial
Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery
Combination product* 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment 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.Secondary outcomes
1
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 completion2
Pathologic complete response
Defined as pT0N0M0
Time frame
From the completion of conversion therapy until surgery, assessed within 8 weeks following treatment completion3
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 years4
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.Sponsors and contacts
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Source ClinicalTrials.gov