癌研連線CancerLink
招募中 NCT06764875

Rilvegostomig聯合氟嘧啶和曲妥珠單抗德魯克斯替康作為HER2陽性胃癌一線治療的Ⅲ期研究

胃癌食道癌皮膚癌Phase IIIIII 期IV 期HER2PD-L1

這是一項Ⅲ期、隨機、開放標籤、贊助商盲試驗、3組、全球、多中心研究，評估rilvegostomig合併氟嘧啶和T-DXd （ A組）與曲妥珠單抗、化療和pembrolizumab （ B組）在腫瘤表現為PD L1 CPS ≥ 1的HER2陽性局部晚期或轉移性胃癌或GEJ腺癌參與者中的療效和安全性。

適應症：HER2-positive Gastric Cancer、Gastroesophageal Junction Adenocarcinoma

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。