Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06560528
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • combination with Disitamab Vedotin and with Tislelizumab and Capecitabine — DRUG
    Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. 1. Disitamab Vedotin：2.5 mg/kg，Q3W； 2. Tislelizumab：200 mg，Q3W； 3. Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

Study Details

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Key Dates

First listed
Aug 19, 2024
Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination with Disitamab Vedotin and with Tislelizumab and Capecitabine
    Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. Disitamab Vedotin：2.5 mg/kg，Q3W； Tislelizumab：200 mg，Q3W； Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

Primary Outcome Measure

Pathologic complete remission rate (PCR) [ Time Frame: up to 1 years ]

Central Contacts

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