A Clinical Study Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression.
报名条件（概要）
- 年龄：18 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
Administer an initial loading dose of 8 mg/kg, followed by 6 mg/kg intravenously. Administer concurrently with chemotherapy, beginning on Day 1 of the first chemotherapy cycle. One cycle consists of 21 days. A total of 6 cycles are administered.
Monotherapy with tegafur for stage IB gastric cancer: Tegafur 40-60 mg (based on body surface area), taken orally twice daily on days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
SOX or XELOX regimens for Stage II gastric cancer: SOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; tegafur 40-60 mg (based on body surface area), taken orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles. XELOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; capecitabine 1000 mg/m², administered orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
This study employs a multicenter randomized controlled trial design, led by the First Affiliated Hospital of Air Force Medical University (Xijing Hospital) in collaboration with 10 other domestic medical institutions, for a total of 11 research centers. The study plans to enroll a total of 120 HER-2-positive gastric cancer patients, including those who drop out, and randomize them into two groups in a 1:1 ratio; The control group received treatment based on gastric cancer stage: Stage IB patients were treated with tegafur monotherapy (40-60 mg orally twice daily based on body surface area, on days 1-14, with a 21-day cycle, for a total of 6 cycles); Stage II patients will receive chemotherapy using either the SOX or XELOX regimen, both of which involve an intravenous infusion of oxaliplatin 130 mg/m² on Day 1, combined with the corresponding oral medications for 14 consecutive days, with a 21-day cycle, for a total of 6 treatment cycles; In addition to the control group's original chemotherapy regimen, the experimental group concurrently received Fuhong Hanlin trastuzumab (National Drug Approval No. S20200019, 150 mg/vial) in addition to the control group's original chemotherapy regimen. The first dose was an 8 mg/kg intravenous loading dose, followed by a maintenance dose of 6 mg/kg, administered concurrently starting on the first day of the first chemotherapy cycle, with each cycle lasting 21 days, and the treatment course consisting of 6 cycles.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Yongzhan Niezhengrong4956@163.com+86 198 2975 8242
中国／港澳台研究中心
- The First Affiliated Hospital of Air Force Military Medical UniversityXi'an，Shaanxi，China
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: A Clinical Study Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression. ClinicalTrials.gov Identifier: NCT07788196 Sponsor: Xijing Hospital Investigational product: Trastuzumab, Monotherapy with tegafur for stage IB gastric cancer, Stage II gastric cancer treated with the SOX or XELOX regimens About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：A Clinical Study Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression. 试验编号：NCT07788196 申办方：Xijing Hospital 研究药物：Trastuzumab、Monotherapy with tegafur for stage IB gastric cancer、Stage II gastric cancer treated with the SOX or XELOX regimens 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
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