OncoMatch/Clinical Trials/NCT06630130
Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Is NCT06630130 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab deruxtecan and Capecitabine for stomach neoplasms.
Treatment: Trastuzumab deruxtecan · Capecitabine · Rilvegostomig — Gastric cancer (GC) is the fifth most commonly diagnosed cancer, with over one million cases diagnosed annually worldwide. Human epidermal growth factor receptor 2 (HER2) overexpression in GC (seen in 4.4% to 53.4% of patients in different reports) is predictive biomarker of response to HER2-targeting therapies. Trastuzumab in combination with cisplatin or oxaliplatin, and a fluoropyrimidine (capecitabine or 5-fluorouracil \[5-FU\]), is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction (GEJ) cancer. Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety, efficacy, PK, RO data as well as modeling analysis. The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of ≥ 90% in the majority of participants across a broad spectrum of conditions. This is a phase II study to initially assess the efficacy of perioperative Trastuzumab Deruxtecan (T-DXd) and Capecitabine combination with or without Rilvegostomig in patients with HER2 positive locally advanced unresectable GC and potentially by subsequent protocol amendment in HER2 low locally advanced GC. Other agents may also subsequently be assessed in this protocol, by protocol amendments
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) IHC 3+ (IHC 3+)
HER2 positive (HER2 IHC 3+ or HER2 IHC 2+/ISH positive)
Required: HER2 (ERBB2) IHC 2+/ISH positive (IHC 2+/ISH positive)
HER2 positive (HER2 IHC 3+ or HER2 IHC 2+/ISH positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (≥8.0 g/dL in GC Indications); Platelet count ≥100 x 10^9/L; Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
Kidney function
CrCL(Ccr) ≥30mL/min (> 45ml/min in Rilvegostomig) as determined by Cockcroft Gault (using actual body weight)
Liver function
Total bilirubin ≤ 1.5 ULN if no liver metastases < 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline; AST (SGOT)/ALT (SGPT) ≤ 3.0 x ULN (< 5×ULN in participants with liver metastases); Serum albumin ≥ 2.5 g/dL
Cardiac function
LVEF ≥ 50% by either echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days before treatment; Mean QT interval corrected for heart rate (QTc) < 470 ms; No clinically important abnormalities in rhythm, conduction or morphology of resting ECG; No symptomatic congestive heart failure (NYHA grade II-IV); Known reduced LVEF < 55% [excluded]; Prior or current cardiomyopathy of any etiology [excluded]; Prior or current acute myocardial infarction within the past 6 months [excluded]; Severe valvular heart disease [excluded]; Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy) [excluded]; Stroke or transient ischaemic attack prior to screening [excluded]; Acute coronary syndrome within 6 months prior to starting treatment [excluded]
Has LVEF ≥ 50%...Has adequate organ and bone marrow, liver and renal function within 14 days before treatment...see details in eligibility criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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