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Not yet recruiting NCT06944496

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

Phase III Interventional Gastric Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine.
Who it may be relevant to
Registry conditions: Gastric Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Randomized Trial Comparing RC48 Plus Chemotherapy and Tislelizumab With Tislelizumab Plus Chemotherapy as First-line Treatment in Participants With HER2 Low Advanced Gastric or Gastrioesophageal Junction Adenocarcinoma (RC48-C039)

Overview

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.

Interventions

  • Biological Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine
    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
  • Biological Tislelizumab+Oxaliplatin+Capecitabine
    Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W

Primary outcome measures

  • Progression-Free Survival [Time frame: 24 months]
Secondary outcome measures (6)
  • Overall Survival [Time frame: up to 5 years]
  • Objective Response Rate [Time frame: 24 months]
  • Disease Control Rate [Time frame: 24 months]
  • Duration of Response [Time frame: 24 months]
  • Patient-Reported Outcomes [Time frame: 24 months]
  • Adverse Events [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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
  • No prior systemic therapy for locally advanced or metastatic gastric cancer
  • HER2-low expression
  • At least one assessable lesion according to RECIST v1.1 criteria
  • Adequate organ function
  • For female subjects: They should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment. A blood pregnancy test must be negative within 7 days before the study medication is administered, and they must not be breastfeeding
  • For male subjects: They should be surgically sterilized or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment
  • Able to understand the study requirements and willing to comply with the study and follow-up procedures

Exclusion criteria

  • Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
  • Peripheral neuropathy > Grade 1
  • Tumor lesions with a tendency to bleed
  • Uncontrolled diarrhea
  • Bone metastases with a risk of paraplegia
  • Past or current interstitial lung disease, or presence of drug-induced pneumonia, radiation pneumonia, or severely impaired lung function
  • Other malignancies within 5 years before the first dose, except for those expected to be cured with treatment (e.g., adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)
  • Pregnant or breastfeeding women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06944496 · RC48-C039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗