Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer
报名条件（概要）
- 年龄：18 Years – 75 Years
- 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
A recombined anti-PD-1/CTLA-4 bispecific antibody (development code QL1706) administered at a fixed dose of 5 mg/kg by intravenous infusion on Day 1 of each 21-day cycle for 4 cycles. This agent is distinguished from conventional immunotherapy by concurrently targeting both PD-1 and CTLA-4 inhibitory pathways within a single molecule, in contrast to sequential or separate use of a PD-1 inhibitor plus ipilimumab (CTLA-4 inhibitor). It is explored here in the neoadjuvant (pre-surgical) window rather than in the metastatic or adjuvant setting.
A triplet chemotherapy backbone given on Day 1 of each 21-day cycle for 4 cycles: nab-paclitaxel 150 mg/m² IV, oxaliplatin 130 mg/m² IV, plus S-1 (tegafur/gimeracil/oteracil) orally 40-60 mg twice daily on Days 1-14 (dose by BSA). This regimen is distinguished from the more common SOX (S-1 + oxaliplatin) or mFOLFOX by the addition of albumin-bound paclitaxel to form a three-drug triplet, and by the inclusion of S-1, an oral fluoropyrimidine more commonly used in Asian gastric-cancer populations.
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。
合作机构
- Qilu Pharmaceutical Co., Ltd.企业
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 is a single-center, single-arm, phase 2 clinical study testing a new neoadjuvant (pre-surgery) treatment for patients with locally advanced gastric cancer or gastroesophageal junction (GEJ) cancer. The treatment combines two parts: (1) a novel bispecific immunotherapy drug, iparomlimab and tuvonralimab (Qibain®) , which helps the immune system attack cancer cells by blocking the PD-1 and CTLA-4 pathways; and (2) a standard chemotherapy regimen called nab-P-SOX, made up of nab-paclitaxel, oxaliplatin, and S-1. About 28 adults (aged 18-75) with previously untreated, HER2-negative, locally advanced gastric or GEJ adenocarcinoma (clinical stage cT3-4aN+M0) will receive this combination before their planned surgery. The main goal is to see how well the tumor shrinks, measured by the objective response rate (RECIST v1.1). Secondary goals include the rate of complete response in the removed tumor tissue (pathological complete response), how often the cancer is removed with clear margins (R0 resection), survival outcomes, and the safety of the treatment. All participants will be closely followed to track both benefits and side effects. The study is sponsored by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, with funding and the study drug provided by Qilu Pharmaceutical Co., Ltd.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
中国／港澳台研究中心
- Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin HospitalShanghai，Shanghai Municipality，China
问自己是否符合条件、如何预筛
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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: Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer ClinicalTrials.gov Identifier: NCT07867392 Sponsor: Ruijin Hospital Investigational product: Iparomlimab and Tuvonralimab (QL1706), nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1） 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：Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer 试验编号：NCT07867392 申办方：Ruijin Hospital 研究药物：Iparomlimab and Tuvonralimab (QL1706)、nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1） 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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