NCT07408609尚未招募2 期
A Phase II Multicenter Randomized Controlled Trial of Perioperative Chemotherapy Combined With Low-Dose Radiotherapy and Tislelizumab Versus Chemotherapy Alone in Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Jiangsu Cancer Institute & Hospital0 个研究点目标入组 114 人开始时间: 2026年2月26日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 主要终点
- Pathological Complete Response (pCR) Rate (ITT Population)
研究概览
简要总结
This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Voluntary participation with written informed consent obtained;
- •Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II/III) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center);
- •Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT);
- •Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1;
- •Presence of measurable and/or non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening);
- •Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.
排除标准
- •History of surgery for gastric or gastroesophageal junction tumors;
- •Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;
- •4.Poor nutritional status, defined as BMI <18.5 kg/m² or PG-SGA score ≥9;
- •Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •Prior or ongoing treatment with anti-PD-1/PD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy;
- •Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids;
- •Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration;
- •Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade >1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.
研究组 & 干预措施
Chemotherapy combined with Tislelizumab
Experimental
干预措施: low-dose radiotherapy (Device)
Chemotherapy combined with Tislelizumab
Experimental
干预措施: Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy (Drug)
Chemotherapy
Active Comparator
干预措施: Chemotherapeutic Agent (Drug)
结局指标
主要结局
Pathological Complete Response (pCR) Rate (ITT Population)
时间窗: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.
The pathological complete response (pCR) rate is defined as the proportion of patients in the intention-to-treat (ITT) population who achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.
次要结局
- Overall Survival (OS)(From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.)
- Pathological Complete Response (pCR) Rate (Surgical Population)(At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.)
- R0 Resection Rate(At the time of surgery, based on pathological evaluation of the resected surgical specimen.)
- Event-Free Survival (EFS)(From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.)
研究者
Gang Li
Clinical Professor
Jiangsu Cancer Institute & Hospital
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