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A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

ConditionGastric Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily consent to participate in the study and sign the informed consent form

Expected survival period >12 weeks

ECOG Performance Status 0 or 1

Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma

Disqualifiers

Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis

Peripheral neuropathy > Grade 1

Tumor lesions with a tendency to bleed

Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disitamab Vedotin

    Drug

    Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;

  • Tislelizumab

    Drug

    Tislelizumab: 200 mg, IV, D1, Q3W

  • CAPOX (oxaliplatin/capecitabine)

    Drug

    Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;

  • Trastuzumab

    Drug

    Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;

  • Pembrolizumab

    Drug

    Pembrolizumab: 200mg, IV, D1, Q3W

Treatment groups

555 Participants
are divided into 2 treatment groups
Group A: Disitamab Vedotin Combined with Trastuzumab and TislelizumabExperimental treatment 3 interventions
Group B: Chemotherapy (CAPOX) Combined with Trastuzumab With or Without PembrolizumabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (assessed by the BIRC)

Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first.

Time frame
24 months

Secondary outcomes

1

Overall Survival

Overall survival (OS) refers to the time from the date of randomization to the date of death from any cause.

Time frame
up to 5 years
2

Progression-Free Survival (assessed by the investigator)

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators or death due to any cause, whichever occurs first.

Time frame
24 months
3

Objective Response Rate (assessed by the BIRC and investigators)

ORR is defined as the percentage of subjects who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 as assessed by BICR and investigators .

Time frame
24 months
4

Disease Control Rate (assessed by the BIRC and investigators)

DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR/ investigators .

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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