Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.

Sponsor
RemeGen Co., Ltd.
Study ID
NCT06155383
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    1000 mg/m2, Bid orally, D1-14, every 3 weeks
  • oxaliplatin — DRUG
    130 mg/m2, intravenous infusion, D1, every 3 weeks
  • Disitamab Vedotin — DRUG
    2.5 mg/kg, intravenous infusion, D1, every 2 weeks
  • Toripalimab — DRUG
    3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Study Details

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Key Dates

First listed
Dec 4, 2023
Start date
Nov 27, 2023
Status verified
Nov 2023
Primary completion
Jan 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: XELOX (capecitabine + oxaliplatin)
    capecitabine with oxaliplatin arm
  • Experimental: Disitamab Vedotin + Toripalimab
    Disitamab Vedotin with Toripalimab arm
  • Experimental: Disitamab Vedotin + Toripalimab + XELOX
    Disitamab Vedotin + Toripalimab + XELOX arm

Primary Outcome Measure

Pathological complete response (pCR) rate [ Time Frame: Up to approximately 2 years ]

Central Contacts

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