Utidelone + Chemotherapy for Gastric Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the combination of a new drug, Utidelone (administered as a capsule), with standard chemotherapy to evaluate its effectiveness and safety for people with advanced stomach cancer. It specifically targets those who have not yet received treatment for their advanced condition. Participants should have stomach or gastroesophageal junction cancer that cannot be surgically removed and should not have received previous treatments for their advanced cancer. The study will also compare different doses of Utidelone to determine the most effective option. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude participants who need to use certain medications that affect liver enzymes or heart rhythm. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using Utidelone with a PD-1 inhibitor and chemotherapy may be effective as an initial treatment for advanced stomach cancer. Studies have found that this combination has an acceptable safety profile, meaning most patients can manage the side effects.
PD-1 inhibitors such as pembrolizumab, nivolumab, and tislelizumab have already received approval for treating advanced stomach cancer. This approval indicates they are generally safe, having been tested in similar patient groups.
Overall, while side effects can occur, many patients have tolerated the treatments in this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Utidelone combined with chemotherapy for gastric cancer because it offers a fresh approach by incorporating a novel agent, Utidelone. Unlike traditional treatments like CAPOX or FOLFOX alone, which are standard chemotherapy regimens, Utidelone has a unique mechanism as a microtubule inhibitor, which can potentially enhance the effectiveness of existing chemotherapy. Moreover, the trial explores the addition of PD-1 inhibitors, such as tislelizumab, pembrolizumab, or nivolumab, which are known to boost the immune system's ability to fight cancer. This combination could offer a more powerful treatment option for patients, potentially improving outcomes compared to current standards.
What evidence suggests that this trial's treatments could be effective for gastric cancer?
In this trial, participants will receive different combinations of treatments to evaluate their effectiveness in treating stomach cancer. Research has shown that Utidelone, one of the treatments being tested, yields promising results when combined with PD-1 inhibitors and chemotherapy. In one study, Utidelone helped 65.2% of patients by shrinking or stabilizing their tumors. Another report indicated that all patients benefited from the treatment, highlighting its strong potential.
PD-1 inhibitors, such as pembrolizumab, nivolumab, and tislelizumab, are also important components of this trial. These inhibitors have been proven to help stomach cancer patients live longer. For instance, nivolumab reduced the risk of death by 37% in some studies. Using these treatments together in this trial might enhance their effectiveness, offering hope for improved outcomes in stomach cancer treatment.16789Are You a Good Fit for This Trial?
This trial is for adults with advanced gastric or gastroesophageal junction adenocarcinoma who haven't had systemic treatment for it. They must have a tumor with low PD-L1, at least one measurable lesion, good physical health (ECOG 0-1), and adequate blood cell counts without recent blood growth factor or transfusions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor, in a 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PD-1 inhibitor
- Utidelone Capsule
Trial Overview
The study tests Utidelone capsules combined with fluoropyrimidine- and platinum-containing therapy in patients. It's an international phase II/III trial to see how effective and safe this combination is compared to standard treatments.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Active Control
UTD2 60 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
UTD2 50 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
UTD2 40 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
UTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX
CAPOX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beijing Biostar Pharmaceuticals Co., Ltd.
Lead Sponsor
Citations
Comparative efficacy and safety of tislelizumab and other ...
Tislelizumab + chemotherapy was associated with significantly lower odds of grade ≥ 3 treatment-related adverse events compared with nivolumab + ...
Efficacy of PD-1/PD-L1 inhibitors in gastric or ... - BMC Cancer
The results suggested that PD-1/PD-L1 inhibitors substantially enhanced overall survival (OS) (HR, 0.91; CI 95%, 0.83–1.00; p = 0.04) but not ...
How to use anti-PD-1 therapy in gastric cancer
The response rate in MSI high patients was 57.1%. Based on these results, pembrolizumab was given conditional approval to treat patients with ...
Immunotherapy Shows Promise Against Previously ...
Compared to the control group, nivolumab treatment was associated with a 37% decrease in risk of death, and 26.6% of patients who received it ...
Effectiveness and safety of anti-PD-1 monotherapy or ...
Of the patients, 16.7% achieved a clinical response, and 72.2% achieved disease control. Prolonged overall survival (OS) and progression-free survival (PFS) and ...
6.
bmcgastroenterol.biomedcentral.com
bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04207-0Efficacy and safety of programmed death-1 inhibitors ...
The present study aimed to investigate the efficacy and safety of PD-1 inhibitors combined with chemotherapy in these patients. Methods. Forty- ...
417P Comparative efficacy and safety of tislelizumab (TIS) ...
Compared to the currently recommended anti–PD-1 therapies, TIS+CT is similarly efficacious while maintaining a similar or more favorable safety profile in the ...
Perioperative PD-1 antibody tislelizumab plus ...
Background: The combination of PD-1 antibody and chemotherapy was shown to be effective in advanced gastric cancer, but has not yet been ...
9.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/08150/efficacy_and_safety_of_pd_1_inhibitors_in.60.aspxEfficacy and safety of PD-1 inhibitors in combination with...
Efficacy and safety of PD-1 inhibitors in combination with chemotherapy as first-line treatment for HER2-negative advanced gastric or ...
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