癌研連線CancerLink
招募中 NCT06764875

Rilvegostomig联合氟嘧啶和曲妥珠单抗德鲁克斯替康作为HER2阳性胃癌一线治疗的Ⅲ期研究

胃癌食管癌皮肤癌Phase IIIIII 期IV 期HER2PD-L1

这是一项Ⅲ期、随机、开放标签、赞助商盲试验、3组、全球、多中心研究，评估rilvegostomig合并氟嘧啶和T-DXd （ A组）与曲妥珠单抗、化疗和pembrolizumab （ B组）在肿瘤表现为PD L1 CPS ≥ 1的HER2阳性局部晚期或转移性胃癌或GEJ腺癌参与者中的疗效和安全性。

适应症：HER2-positive Gastric Cancer、Gastroesophageal Junction Adenocarcinoma

入组条件

纳入标准

  • HER2 positive for gastric cancer on a tumor biopsy.
  • PD-L1 combined positive score (CPS) ≥ 1.
  • Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
  • WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have measurable target disease assessed by the Investigator based on RECIST v1.1.
  • Have adequate organ and bone marrow function.
  • LVEF ≥ 50% within 28 days before randomization.
  • Adequate treatment washout period before randomization.

排除标准

  • Lack of physiological integrity of the upper gastrointestinal tract.
  • Known dihydropyrimidine dehydrogenase enzyme deficiency.
  • Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
  • Persistent toxicities caused by previous anti-cancer therapy.
  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
  • Uncontrolled infection including tuberculosis and active hepatitis A infection.
  • Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
  • Recent receipt of live, attenuated vaccine.
  • Chronic/active HBV or HCV infection unless controlled.
  • Clinically significant cardiac or psychological conditions.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
  • History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Lung-specific intercurrent clinically significant illnesses.
  • Any active non-infectious skin disease requiring systemic treatment.
  • A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
  • History of any of the following: drug-induced severe cutaneous adverse reaction.
  • Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
  • Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
  • Current or prior use of immunosuppressive medication within 14 days before study intervention.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。