Tislelizumab for Stomach Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new drug, tislelizumab, for stomach cancer that cannot be surgically removed or has metastasized. Researchers aim to determine if administering the drug via a subcutaneous injection is as effective as an IV drip, both in combination with chemotherapy. The trial seeks participants with advanced stomach or gastroesophageal junction cancer who have not received prior treatment for their condition. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tislelizumab, whether administered as a shot under the skin or through an IV, generally maintains a safety profile similar to chemotherapy alone. Studies have found that combining tislelizumab with chemotherapy does not significantly increase the risk of serious side effects compared to chemotherapy alone.
For the IV form, some patients reported lung inflammation, occurring in about 4.7% of cases, with very few being severe. Overall, most side effects were manageable and not life-threatening.
The shot form has also been studied and did not worsen surgery-related complications in patients with advanced stomach cancer.
In summary, both forms of tislelizumab appear well-tolerated when used with chemotherapy, with side effects generally consistent with those expected from cancer treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tislelizumab for stomach cancer because it offers a new way to unleash the immune system against cancer cells. Unlike standard chemotherapy, which directly attacks cancer cells, Tislelizumab is an immunotherapy that works by blocking a protein called PD-1, helping the immune system recognize and destroy cancer cells more effectively. The trial is exploring two methods of delivery: a subcutaneous injection and an intravenous infusion, providing flexibility and potentially improved convenience for patients. This approach could enhance treatment effectiveness and offer new hope for those with advanced stomach cancer.
What evidence suggests that this trial's treatments could be effective for stomach cancer?
Research shows that tislelizumab may help treat advanced stomach cancer. In this trial, participants will receive either Tislelizumab Subcutaneous with chemotherapy or Tislelizumab Intravenous Infusion with chemotherapy. Studies have found that combining tislelizumab with chemotherapy improved survival rates compared to chemotherapy alone. Specifically, one study reported a 93.5% response rate and a 100% disease control rate in patients with advanced stomach cancer. Another study demonstrated a 20% decrease in the risk of disease progression or death when using tislelizumab. These findings suggest that tislelizumab could be effective for treating advanced stomach and gastroesophageal junction cancers.678910
Who Is on the Research Team?
Study Director
Principal Investigator
BeOne Medicines
Are You a Good Fit for This Trial?
This trial is for adults with advanced gastric or gastroesophageal junction adenocarcinoma that can't be surgically removed or has spread. Participants will receive tislelizumab via injection or infusion plus chemotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tislelizumab administered as a subcutaneous injection or intravenous infusion plus chemotherapy on Day 1 of each 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Leucovorin, Capecitabine, Cisplatin, 5-fluorouracil (5-FU), Oxaliplatin
- Tislelizumab
Trial Overview
The study compares drug exposure levels between subcutaneous injection and intravenous infusion of Tislelizumab, combined with chemotherapy drugs like Leucovorin, Capecitabine, Cisplatin, 5-FU, and Oxaliplatin in around 351 patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeOne Medicines
Lead Sponsor
BeiGene
Lead Sponsor
Citations
patient-reported outcomes in the RATIONALE-305 study
Objective: RATIONALE-305 (NCT03777657) demonstrated that tislelizumab plus chemotherapy statistically improved overall survival versus placebo plus chemotherapy ...
2.
onclive.com
onclive.com/view/tislelizumab-plus-chemotherapy-is-active-tolerable-in-advanced-gastric-gej-cancerTislelizumab Plus Chemotherapy Is Active, Tolerable in ...
Tislelizumab plus POFI showed promising efficacy in advanced gastric cancer with a 93.5% objective response rate and 100% disease control rate.
3.
oncologynewscentral.com
oncologynewscentral.com/drug/fda-approves-tislelizumab-combo-for-gastric-or-gastroesophageal-junction-cancerFDA Approves Tislelizumab Combo for Gastric or ...
Results showed that adults with advanced unresectable or metastatic gastric and GEJ cancers who received tislelizumab plus the investigator's ...
4.
targetedonc.com
targetedonc.com/view/tislelizumab-scores-fda-approval-in-advanced-gastric-and-gej-cancersTislelizumab Scores FDA Approval in Advanced Gastric ...
In the study, tislelizumab given in combination with chemotherapy demonstrated a 20% reduction in the risk of disease progression or death.
Tislelizumab first-line (1L) gastric/gastroesophageal ...
Tislelizumab was associated with a 21% reduction in risk of death (P=0.0269). Conclusions: In this analysis, compared with chemo, tislelizumab + ...
1L GC/GEJC Safety | TEVIMBRA® (tislelizumab-jsgr) | HCPs
Immune-mediated pneumonitis occurred in 4.7% (113/2390) of patients receiving TEVIMBRA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (1.4%), and Grade 2 (1.9 ...
TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use
TEVIMBRA may be used alone when your esophageal cancer: o is a type called squamous cell carcinoma, and o cannot be removed with surgery or has spread to other ...
Tevimbra (tislelizumab) dosing, indications, interactions, ...
Medscape - Esophageal and gastric cancer dosing for Tevimbra (tislelizumab), frequency-based adverse effects, comprehensive interactions, contraindications, ...
Tislelizumab-jsgr (Tevimbra) - Medical Clinical Policy ...
Aetna considers tislelizumab-jsgr (Tevimbra) medically necessary for treatment of HER2-negative gastric adenocarcinoma in members who are not surgical ...
10.
mayoclinic.org
mayoclinic.org/drugs-supplements/tislelizumab-jsgr-intravenous-route/description/drg-20565521Tislelizumab-jsgr (intravenous route) - Side effects & uses
Tislelizumab-jsgr injection is used in combination with platinum-containing chemotherapy as first-line treatment of esophageal squamous cell carcinoma (ESCC)
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