Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2028

Conditions
Gastric CancerHER2-positive Gastric Cancer
Interventions
DRUG

Experimental

6 cycles of: T-DXd at the dose of 6.4 mg/kg intravenous every 3 weeks plus capecitabine 1000 mg/sqm BID orally on days 1-14 every 3 weeks or 5-fluorouracil 600 mg/m2/day continuous intravenous infusion on days 1-5 every 3 weeks as per Investigator's choice

DRUG

Control

4 cycles of: 5-fluorouracil 2600 mg/m2 continuous intravenous infusion day 1 for 24 hours every 2 weeks, leucovorin 200 mg/m2 intravenous infusion on day 1 every 2 weeks, oxaliplatin 85 mg/m2 intravenous infusion on day 1 every 2 weeks, and docetaxel 50 mg/m2 intravenous infusion on day 1 every 2 weeks.

Trial Locations (1)

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan

All Listed Sponsors
lead

Gruppo Oncologico del Nord-Ovest

OTHER