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

RemeGen

Status and phase

Not yet enrolling

Phase 3

Conditions

Gastric Carcinoma

Treatments

Biological: Tislelizumab+Oxaliplatin+Capecitabine

Biological: Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06944496

RC48-C039

Details and patient eligibility

About

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.

Enrollment

616 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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