Utidelone + Chemotherapy for Gastric Cancer

Recruiting at 9 trial locations

Overseen By Rongguo Qiu

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: HER2-positive, Other malignancies, Uncontrolled diabetes, Severe cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

778 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

Are 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

I have signed the consent form to participate in the study.

My cancer is advanced and cannot be removed by surgery.

My tumor's PD-L1 score is less than 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor, in a 21-day cycle

12 months

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?

Group I: Cohort 3 Experimental Treatment 5 Interventions

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 )

Group II: Cohort 2 Experimental Treatment 5 Interventions

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 )

Group III: Cohort 1 Experimental Treatment 5 Interventions

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 )

Group IV: Arm A Experimental Treatment 3 Interventions

UTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX

Group V: Arm B Active Control 2 Interventions

CAPOX

Who Is Running the Clinical Trial?

Beijing Biostar Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

15

Recruited

3,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12630173/

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 + ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10605-y

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 ...

3. cco.amegroups.org cco.amegroups.org/article/view/121790/html

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 ...

4. cancerresearch.org cancerresearch.org/blog/immunotherapy-shows-promise-against-stomach-cancer

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9850086/

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/s12876-025-04207-0

Efficacy 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- ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00636-2/fulltext

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 ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4083

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.aspx

Efficacy 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 ...