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Compares treatment options for Gastric Carcinoma
Official title 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.
ClinicalTrials.gov ID: NCT07315750
What this study is testing
What is Disitamab Vedotin?
Disitamab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
- No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after...
You likely can't join if
- 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
- Bone metastases with a risk of paraplegia
- Past or current interstitial lung disease, or severely impaired lung function
See the full eligibility 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 or metastatic --gastric/gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
- HER2-high expression
- At least one assessable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Female people of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until...
- Able to understand the study requirements and willing to comply with the study and follow-up procedures
- 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
- Bone metastases with a risk of paraplegia
- Past or current interstitial lung disease, or severely impaired lung function
- Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, BJ-Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, BJ-Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.