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A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

ConditionGastric Carcinoma
Trial statusNot yet recruiting
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 Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX\*\* as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.

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, metastatic, or recurrent gastric or 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

Uncontrolled diarrhea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine

    Biological/Vaccine

    Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 100 mg/m², IV, D1, Q3W; Capecitabine: 750 mg/m², po, BID, D1-D14, Q3W

  • Tislelizumab+Oxaliplatin+Capecitabine

    Biological/Vaccine

    Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W

Treatment groups

616 Participants
are divided into 2 treatment groups
Group A: Tislelizumab combined with CAPOXActive comparator 1 intervention
Group B: Disitamab Vedotin Combined with Tislelizumab and CAPOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival

Time frame
24 months

Secondary outcomes

1

Overall Survival

Time frame
up to 5 years
2

Objective Response Rate

Time frame
24 months
3

Disease Control Rate

Time frame
24 months
4

Duration of Response

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

This trial is not recruiting at the moment. You can still explore other options: