Tislelizumab plus chemotherapy for advanced gastric, gastroesophageal, and esophageal squamous cancers in U.S. racial and ethnic minority patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study giving the anti–PD-1 antibody tislelizumab together with standard chemotherapy (capecitabine or 5‑FU, oxaliplatin, and leucovorin) to adults with HER2‑negative, PD‑L1‑positive, unresectable or metastatic gastric/gastroesophageal adenocarcinoma or esophageal squamous cell carcinoma who self-identify as members of U.S. racial and ethnic minority groups. Participants must have no prior systemic therapy for advanced disease, an ECOG performance status of 0–1, and at least one measurable lesion per RECIST v1.1. The study will collect pharmacokinetics, safety, and anti-tumor activity data, with tumor response measured by RECIST criteria and safety monitored throughout treatment. Total participation may last up to about six years to capture longer-term outcomes and safety information.

Why it matters

Who can join: the full rules

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:

  1. Controlled Type I diabetes
  2. Hypothyroidism (provided it is managed with hormone replacement therapy only)
  3. Controlled celiac disease
  4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
  5. 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.

Where it's running

• Pioneer Research Center
  Bullhead City, Arizona, United States Recruiting
• Helios Clinical Research
  Cerritos, California, United States Recruiting
• Los Angeles Cancer Network
  Los Angeles, California, United States Recruiting
• Brcr Coral Springs
  Coral Springs, Florida, United States Recruiting
• Bioresearch Partners Holding Hialeah Hospital
  Hialeah, Florida, United States Recruiting
• Florida Clinical Trials Group Plantation
  Plantation, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

  This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• BL-B01D1 with Tislelizumab ± 5-FU as first-line treatment for unresectable, locally advanced recurrent, or metastatic esophageal squamous cell carcinoma

  A phase II/III trial tests BL-B01D1 with tislelizumab, with or without 5-FU, against standard platinum-based chemotherapy plus tislelizumab for adults with unresectable or metastatic esophageal squamous cell carcinoma.

  Recruiting Phase 2/3 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07554456

• Combining short-course radiotherapy with Raltitrexed and Tislelizumab for advanced esophageal cancer

  This study is testing a new treatment that combines short radiation therapy with two medications to see if it helps people with advanced esophageal cancer that has come back or gotten worse.

  Recruiting Anhui Provincial Hospital · Hefei · NCT06408584

• Combining Tislelizumab and S-1 for Esophageal Cancer Treatment

  This study is testing a new combination of two drugs, Tislelizumab and S-1, to see if it can help patients with esophageal cancer who have had surgery and still have some cancer left.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Chongqing Municipality · NCT06354140

• Combining Tislelizumab with Chemotherapy for Esophageal Cancer Treatment

  This study is testing if combining a new immune therapy called tislelizumab with chemotherapy can help people with esophageal cancer live longer and stay cancer-free after surgery.

  Recruiting Phase 2 Shanghai Chest Hospital · Shanghai, Shanghai Municipality · NCT06056336

• Combining chemotherapy with Tislelizumab for esophageal cancer after surgery

  This study is testing if combining an immunotherapy drug called Tislelizumab with chemotherapy can help people with esophageal cancer live longer after surgery.

  Recruiting Phase 1 Affiliated Cancer Hospital of Shantou University Medical College · Shantou, Guangdong · NCT05984342

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.