Disitamab Vedotin Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer With HER2 Overexpression: a Prospective, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Pathological Complete Response Rate (pCR)
研究概览
简要总结
This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.
详细描述
The study plans to enroll 32 subjects. After signing the informed consent form and meeting the inclusion and exclusion criteria, patients will receive standard-dose treatment of the RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery. Apatinib will only be used for 14 days in the last cycle. Imaging studies will be conducted 3-4 weeks after the last dose to assess the efficacy of neoadjuvant therapy and the possibility of radical D2 gastrectomy. The treatment plan after curative surgery for gastric cancer will be determined by the investigators and the patients based on the pathological findings. Patients who benefit clinically after surgery may receive adjuvant therapy with RC48, Adebrelimab, Apatinib and S-1 for 4 cycles (the first treatment is expected to start around 4 weeks after surgery) or follow the standard postoperative adjuvant regimen recommended by the guidelines.
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
- •Participants voluntarily join this study, are able to complete the signing of the informed consent form, and have good compliance;
- •Age between 18 to 75 years old (at the time of signing the informed consent form), with no gender restrictions;
- •Gastrointestinal cancer or gastroesophageal junction adenocarcinoma confirmed by histology and/or cytology, diagnosed as locally advanced according to the 8th edition of the AJCC standards, with a cTNM diagnosis of T3-4aN+M0 and T4aNanyM0 based on ultrasound endoscopy or enhanced CT/MRI scan (and diagnostic laparoscopy if necessary), and agree to receive curative surgical treatment, with the investigator assessing the potential for tumor resectability;
- •Have not previously received systemic treatment for the current disease, including anti-tumor chemotherapy/immunotherapy, etc.;
- •HER2 overexpression confirmed by IHC results from endoscopic biopsy tissue (defined as: IHC 2+, 3+);
- •ECOG score of 0-1;
- •Estimated life expectancy of ≥6 months;
- •Good major organ function:
排除标准
- •Concurrent malignant disease other than gastric cancer (excluding early-stage tumors that have been radically treated);
- •Tumor lesions with a tendency to bleed (such as active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, or assessed by the investigator as being at risk of significant gastrointestinal hemorrhage, etc.) or having received blood transfusion treatment within 4 weeks before the study medication;
- •Inability to take oral medication;
- •Currently participating in another interventional clinical study treatment, or having received other investigational drugs or used investigational medical devices within 4 weeks before the first administration of the study medication;
- •Has had systemic treatment required within 2 years before the first administration of the study medication;
- •Known allogeneic organ transplantation (except for corneal transplantation);
- •Known allergy to any medication used in this study;
- •Peripheral neuropathy of grade ≥2;
- •Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies);
- •Active hepatitis B or C infection;
- •Received live vaccines within 30 days before the first administration (Day 1 of Cycle 1);
- •Pregnant or breastfeeding women;
- •Presence of any severe or uncontrollable systemic disease.
研究组 & 干预措施
Experimental
RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.
干预措施: RC48 (Drug)
Experimental
RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.
干预措施: Adebrelimab (Drug)
Experimental
RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.
干预措施: Apatinib (Drug)
Experimental
RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.
干预措施: S-1 (Drug)
结局指标
主要结局
Pathological Complete Response Rate (pCR)
时间窗: 4 months
Defined as the proportion of subjects with no residual viable tumor cells on microscopy and negative lymph nodes out of the total number of subjects;
次要结局
- R0 Resection rate(4 months)
- Disease-Free Survival (DFS）(24 months)
- Major Pathological Response rate (MPR)(4 months)
- Overall Survival (OS)(36 months)