Tislelizumab + Chemotherapy for Gastric Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effects of combining tislelizumab with chemotherapy on certain stomach and esophagus cancers. It targets patients whose cancer cannot be surgically removed and who belong to racial or ethnic minority groups. Individuals diagnosed with HER2-negative, PD-L1-positive gastric or esophageal cancer who have not received prior treatment may qualify. The trial aims to assess the treatment's effectiveness and safety for these patients. As a Phase 2 trial, it measures the treatment's efficacy in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on corticosteroids or other immunosuppressive medications, you may need to stop them at least 14 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that tislelizumab is safe. Data from real-world use in patients with advanced esophageal squamous cell carcinoma (ESCC) suggest that tislelizumab, when combined with chemotherapy, is well-tolerated. These studies found that tislelizumab had a similar safety level to other treatments, with fewer severe side effects. While some patients experienced side effects, fewer of these were serious compared to using chemotherapy alone.
The FDA has approved tislelizumab for treating metastatic esophageal cancer, which supports its safety. However, since this study is in Phase 2, researchers continue to collect detailed safety information. Existing data suggests that tislelizumab is generally safe for patients who qualify for the study.12345Why are researchers excited about this trial's treatments?
Tislelizumab is unique because it enhances the immune system's ability to fight gastric cancer by targeting the PD-1 pathway, a mechanism not commonly used in standard chemotherapy treatments like FOLFOX, CAPOX, or cisplatin-based regimens. This targeted approach potentially increases the immune system's effectiveness against cancer cells, which is different from traditional therapies that mainly attack cancer cells directly. Researchers are excited because this could lead to more effective treatment options with potentially fewer side effects, offering hope for improved patient outcomes in gastric cancer.
What evidence suggests that this trial's treatments could be effective for gastric cancer?
Research has shown that combining tislelizumab with chemotherapy may help treat stomach and gastroesophageal cancers. In this trial, participants with Gastric/Gastroesophageal Adenocarcinoma will receive tislelizumab alongside one of several chemotherapy regimens. One study found that this combination led to patients living about 15 months on average, longer than those who received a placebo with chemotherapy. In patients with advanced stomach cancer, 93.5% experienced a reduction in tumor size. For Esophageal Squamous Cell Carcinoma, participants will receive tislelizumab with FOLFOX chemotherapy. Studies suggest that tislelizumab with chemotherapy helped patients live longer compared to chemotherapy alone. These findings indicate that tislelizumab could be an effective treatment option for these types of cancer.16789
Who Is on the Research Team?
Study Director
Principal Investigator
BeOne Medicines
Are You a Good Fit for This Trial?
This trial is for US racial and ethnic minority adults with HER2-negative, PD-L1-positive stomach or esophageal cancer that cannot be removed by surgery or has spread. Participants must not have had prior treatment for advanced disease, need to have good organ function, and agree to use birth control if needed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tislelizumab plus chemotherapy according to specified regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term safety and efficacy outcomes
What Are the Treatments Tested in This Trial?
Interventions
- 5-fluorouracil (5-FU)
- Capecitabine
- Leucovorin
- Oxaliplatin
- Tislelizumab
Trial Overview
The study tests the combination of tislelizumab (an immunotherapy drug) plus chemotherapy drugs (capecitabine, leucovorin, 5-fluorouracil, oxaliplatin) in people with advanced gastric or esophageal cancers. The goal is to see how safe and effective this combo is over about 6 years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeOne Medicines
Lead Sponsor
Citations
Assessment of efficacy, safety and survival of tislelizumab as ...
In real-world data, tislelizumab as a neoadjuvant therapy for patients with locally advanced ESCC patients demonstrated excellent safety and ...
Tislelizumab (TIS; BGB-A317) plus chemotherapy (CT) ...
Background: Studies have shown overall survival improvements with nCRT + surgery vs surgery alone in locally advanced ESCC.
3.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41410741/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1V7FV1QUbN6XMScKFZst79sHh5u920fTmr_-oSLq5hQZXmCEyc&fc=None&ff=20251218144426&v=2.18.0.post22+67771e2Long-term outcome of neoadjuvant tislelizumab plus ...
Conclusions: Neoadjuvant tislelizumab combined with chemotherapy demonstrated promising efficacy with encouraging pathological responses and ...
4.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/10002/s1059_efficacy_and_safety_of_tislelizumab_in.1060.aspxS1059 Efficacy and Safety of Tislelizumab in Esophageal...
Tislelizumab demonstrates encouraging efficacy in ESCC with high 1-year PFS and OS rates, notable response rates (ORR, DCR, pCR), and manageable safety profile.
5.
targetedonc.com
targetedonc.com/view/tislelizumab-plus-chemotherapy-improves-overal-survival-in-esccTislelizumab Plus Chemotherapy Improves Overall ...
In the trial, the median overall survival in the tislelizumab arm was 17.2 months (95% CI 15.8-20.1) vs 10.6 months (95% CI, 9.3-12.1) in the ...
Tislelizumab efficacy and safety compared to other anti–PD ...
Tislelizumab + CT is an effective 1L treatment option for advanced or metastatic ESCC, demonstrating comparable efficacy and safety outcomes ...
Safety and efficacy of tislelizumab plus chemotherapy for first ...
Moreover, the objective response rates and disease control rates for both ESCC and G/GEJ adenocarcinoma were 46.7% and 80.0%, respectively. The ...
Tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) ...
Efficacy outcomes (OS, progression-free survival [PFS], objective response rate [ORR], duration of response [DoR]) and safety were analyzed.
New Phase III data show Novartis tislelizumab significantly ...
First-line tislelizumab plus chemotherapy showed median overall survival of 17.2 months versus 10.6 months for chemotherapy and reduced risk ...
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