Is NCT07554521 recruiting in Hialeah, FL?

Yes, NCT07554521 is currently recruiting participants at its Hialeah, FL location. This advanced unresectable gastric adenocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Hialeah clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Unresectable Gastric Adenocarcinoma Clinical Trial in Hialeah, FL

Q: How do I join the advanced unresectable gastric adenocarcinoma clinical trial in Hialeah?

To join this clinical trial in Hialeah, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Advanced Unresectable Gastric Adenocarcinoma Study in Hialeah

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.

Sponsor: BeOne Medicines

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hialeah?

Yes, this clinical trial (NCT07554521) has an active research site in Hialeah, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Unresectable Gastric Adenocarcinoma Treatment Options in Hialeah, FL

If you're searching for advanced unresectable gastric adenocarcinoma treatment options in Hialeah, FL, this clinical trial (NCT07554521) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hialeah research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced unresectable gastric adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced unresectable gastric adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Advanced Unresectable Gastric Adenocarcinoma Clinical Trial in Hialeah, FL

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