Advanced Unresectable Gastric AdenocarcinomaPhase 2NCT07554521
A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
A Phase 2 study testing Tislelizumab, Capecitabine and 5-fluorouracil (5-FU) in people with Advanced Unresectable Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma, run by BeOne Medicines at 9 sites in United States.
Trial summary
The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Advanced Gastroesophageal Adenocarcinoma
- What is being tested?
- Tislelizumab, Capecitabine and 5-fluorouracil (5-FU)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Apr 2026to 31 Dec 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as a member of racial and/or ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander
- Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous cell carcinoma (ESCC)
- No previous systemic therapy for locally advanced unresectable or metastatic GAC/GEA or ESCC
- At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment
- Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable
- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1
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- Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment
- Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of tislelizumab and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment
- Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab and ≥ 180 days after the last dose of chemotherapy
Who cannot join
- Patient has squamous cell or undifferentiated or other histological type gastric cancer
- Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before study treatment.
- Patients with evidence of esophageal/bronchial or esophageal/aorta fistula, or complete esophageal obstruction not amenable to treatment.
- Diagnosed with GAC/GEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment
- Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:
- Controlled Type I diabetes
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- Hypothyroidism (provided it is managed with hormone replacement therapy only)
- Controlled celiac disease
- Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
- Any other disease that is not expected to recur in the absence of external triggering factors
- Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)
- Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment
- Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and/or fistulae (including prior gastric fistula operation) within 6 months prior to study treatment
- Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Pioneer Research Center
Bullhead City, Arizona, 86442
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718-2566
- Recruiting
Helios Clinical Research
Cerritos, California, 90703
- Recruiting
Brcr Coral Springs
Coral Springs, Florida, 33065
- Recruiting
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, 33013-3804
- Recruiting
Los Angeles Cancer Network
Los Angeles, California, 90017-4803
- Recruiting
Florida Clinical Trials Group Plantation
Plantation, Florida, 33322
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110-1010
- Recruiting
Florida Clinical Trials Group Tamarac
Tamarac, Florida, 33321
About this study
Official title: An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients
The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC/GEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.
- Conditions
- Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Advanced Gastroesophageal Adenocarcinoma
- Being tested
- Tislelizumab, Capecitabine, 5-fluorouracil (5-FU), Oxaliplatin, Leucovorin
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
Administered by intravenous infusion
CapecitabineDrug
Administered orally
5-fluorouracil (5-FU)Drug
Administered by intravenous infusion
OxaliplatinDrug
Administered by intravenous infusion
LeucovorinDrug
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA) | Experimental | Participants will receive tislelizumab (either 200 mg every 3 weeks or 150 mg every 2 weeks, matching the chemotherapy regimen) and one of the following chemotherapy regimens:
* FOLFOX: oxaliplatin 85 mg + leucovorin on Day 1, followed by 5-fluorouracil (5-FU) (2400 to 2800 mg) IV, repeated every 2 weeks (Q2W).
* CAPOX: oxaliplatin 130 mg Day 1 + capecitabine 1000 mg orally twice daily for consecutive 14 days, repeated every 3 weeks (Q3W).
* Cisplatin 80 mg Day 1 + 5-FU 800 mg IV continuous infusion over 24 hours daily on Day 1 to Day 5, repeated Q3W. Receives: Drug: Tislelizumab; Drug: Capecitabine; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Leucovorin |
| Esophageal Squamous Cell Carcinoma (ESCC) | Experimental | Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy. Receives: Drug: Tislelizumab; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAEv5.0][1]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively
Measured: Approximately 12 months
Secondary outcomes (3)
Overall Response Rate (ORR) as Assessed by the Investigator
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Approximately 12 months
Serum Concentrations of Tislelizumab
Measured: Approximately 12 months
Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start30 Apr 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Unresectable Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554521
- Sponsor's protocol ID
- BGB-A317-217
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.