A Phase Ib/II Clinical Trial of the XELOX Regimen Combined With Sintilimab and Hyperbaric Oxygen Therapy for the Treatment of Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
This study investigates the efficacy and safety of XELOX chemotherapy combined with sintilimab and hyperbaric oxygen therapy (HBOT) as a first-line treatment for patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma. The trial comprises two phases: a phase Ib study to determine the optimal HBOT regimen and assess safety and tolerability, followed by a phase II study to evaluate the overall response rate (ORR). Secondary outcomes include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (OS), safety, and quality of life. This study aims to provide a novel approach for enhancing therapeutic efficacy and improving patient outcomes by leveraging HBOT to address tumor hypoxia and augment the effects of chemotherapy and immune checkpoint inhibitors.
详细描述
This is a prospective, single-arm, phase Ib/II clinical trial designed to evaluate the safety and efficacy of the XELOX regimen combined with sintilimab and hyperbaric oxygen therapy (HBOT) in patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma.
In the phase Ib portion, 9 patients will be enrolled to identify the optimal HBOT protocol and assess the safety and tolerability of the combined treatment. The dose and schedule of HBOT will be refined based on observed safety data and adverse events.
In the phase II portion, approximately 48 patients will be enrolled to further evaluate the efficacy of the XELOX plus sintilimab and HBOT combination. Patients will receive treatment in 3-week cycles, with HBOT administered alongside chemotherapy and immunotherapy. The primary endpoint of the phase II study is the overall response rate (ORR) assessed per RECIST 1.1 criteria.Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (OS), safety profile, and patient-reported outcomes related to quality of life. Exploratory endpoints will focus on biomarker analysis and the role of HBOT in modulating tumor hypoxia.This study aims to explore whether HBOT can enhance the efficacy of chemotherapy and immunotherapy by addressing tumor hypoxia, a known factor contributing to therapy resistance in gastric and gastroesophageal junction cancers. The findings from this trial may provide insights into a novel multimodal treatment strategy for improving patient outcomes in advanced disease settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
XELOX+Sintilimab+HBOT
Patients will receive the XELOX regimen, consisting of oxaliplatin (130 mg/m² IV on Day 1) and capecitabine (1000 mg/m² orally twice daily for 14 days, repeated every 3 weeks), combined with sintilimab (200 mg IV on Day 1 every 3 weeks) and hyperbaric oxygen therapy (HBOT) administered alongside the XELOX regimen. Treatment will be administered for 4 to 6 cycles.
Following the initial treatment phase, patients will be evaluated for response. If disease progression is observed, patients will exit the study and receive subsequent treatments as deemed appropriate. For patients with stable disease or a response to therapy, maintenance treatment with capecitabine and sintilimab will continue until the occurrence of a study endpoint or other specified criteria.
干预措施: XELOX+Sintilimab+HBOT (Drug)
结局指标
主要结局
ORR
时间窗: ORR will be assessed after 4 to 6 cycles of treatment (approximately 12 to 18 weeks). Evaluation will include imaging performed at baseline and at the end of the treatment cycles to determine the tumor response.
The primary outcome measure is the overall response rate (ORR), defined as the proportion of patients achieving a complete response (CR) or partial response (PR) as assessed by RECIST 1.1 criteria. ORR will be evaluated based on imaging and clinical assessments conducted during the study.
次要结局
- Progression-Free Survival (PFS)(From the start of treatment to the first disease progression or death, assessed up to approximately 24 months.)
- Disease Control Rate (DCR)(After 4-6 cycles of treatment (approximately 12-18 weeks).)
- Downstaging Rate(After 4-6 cycles of treatment (approximately 12-18 weeks).)
- 2-Year Disease-Free Survival (DFS)(From the start of treatment to 2 years post-treatment.)
- 2-Year Overall Survival (OS)(From the start of treatment to 2 years post-treatment.)
- Adverse Events(From the start of treatment to the end of the study (up to approximately 24 months).)
- Quality of Life (QoL)(Baseline, every 3 weeks during treatment, and every 12 weeks post-treatment, up to 24 months.)
研究者
Ming Liu
Clinical Professor
West China Hospital