Actively Recruiting
A Phase III Randomized Study of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) with Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced HER2-High Gastric or Gastroesophageal Junction Adenocarcinoma
Led by RemeGen Co., Ltd. · Updated on 2026-01-21
555
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining Disitamab Vedotin, Trastuzumab, and Tislelizumab compared with chemotherapy combined with Trastuzumab, with or without Pembrolizumab, as a first treatment for advanced gastric or gastroesophageal junction adenocarcinoma that has high HER2 expression. This phase III randomized study focuses on patients who have not received prior systemic therapy for their advanced cancer or whose disease returned at least six months after previous treatment. The study aims to better understand treatment outcomes in this specific patient group. Participants will be randomly assigned to one of two treatment groups. One group will receive Disitamab Vedotin at 2.5 mg/kg intravenously every two weeks along with Trastuzumab and Tislelizumab every three weeks until unacceptable side effects, disease progression, or other reasons for stopping treatment occur. The other group will receive chemotherapy with CAPOX (oxaliplatin and capecitabine), Trastuzumab, and, if their PD-L1 expression is confirmed as CPS ≥1, Pembrolizumab every three weeks. Treatment continues under similar stopping conditions. During the study, participants will be regularly monitored for disease progression, overall survival, response rates, disease control, and duration of response using assessments by blinded central review committees and investigators for up to 24 months, with some outcomes tracked for up to five years. Patient-reported quality of life and adverse events will also be collected. The study includes follow-up visits and evaluations to assess safety and effectiveness over the course of the trial, which starts in 2026 and may continue through 2030.
CONDITIONS
Brief 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily consent to participate and sign the informed consent form
- Expected survival period greater than 12 weeks
- ECOG Performance Status of 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 or more after neoadjuvant/adjuvant therapy
- HER2-high expression
- At least one assessable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to first treatment and agree not to breastfeed or donate ova from consent signing until 6 months after last treatment
- Male subjects must agree not to donate sperm from consent signing until 6 months after last treatment
- Able to understand study requirements and willing to comply with study and follow-up procedures
You will not qualify if you...
- Presence of central nervous system metastasis and/or carcinomatous meningitis
- Peripheral neuropathy greater than Grade 1
- Tumor lesions with a tendency to bleed
- Severe gastrointestinal dysfunction affecting drug intake, transport, or absorption
- Bone metastases with risk of paraplegia
- Past or current interstitial lung disease or severely impaired lung function
- Other malignancies within 5 years prior to randomization, except those expected to be cured with treatment
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until intolerable toxicity, disease progression, or other discontinuation criteria
Participants receive study treatments including Disitamab Vedotin, Trastuzumab, and Tislelizumab, or Chemotherapy (CAPOX) combined with Trastuzumab with or without Pembrolizumab, depending on PD-L1 expression. Treatment continues until intolerable toxicity, disease progression, new therapy initiation, withdrawal, loss to follow-up, or death.
Visits every 1 to 3 weeks depending on treatment schedule
Duration - Up to 5 years
Participants are monitored for survival and long-term outcomes after treatment ends.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, BJ-Beijing, China, 100021
Actively Recruiting
Research Team
H
Hongfang Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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