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Utidelone Capsule for Gastric or Gastroesophageal Junction Adenocarcinoma

This study is testing Utidelone Capsule in combination with standard chemotherapy (fluoropyrimidine- and platinum-containing therapy, like CAPOX) for people with advanced gastric (stomach) or gastroesophageal junction (where the esophagus meets the stomach) adenocarcinoma. The goal is to see how safe and effective this combination is as a first treatment. Researchers will be looking at how well patients tolerate the treatment and how long they live. You may be able to join if you are 18 or older and have not had previous systemic treatment for your advanced cancer. The study plans to enroll 778 participants.

Study design
This is a multi-national, open-label (meaning you and your doctors will know what treatment you are receiving), randomized (meaning you will be assigned to a treatment group by chance) study. It is designed to seamlessly combine Phase II and Phase III research.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured at 12 months after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06841679

Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Beijing Biostar Pharmaceuticals Co., Ltd.
~778 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:Utidelone CapsuleFluoropyrimidine- and Platinum-containing TherapyOxaliplatinPD-1 inhibitorCapecitabine

At a glance

Recruiting sites
6 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase II
Measured over From Day 1 to Day 21
+1 more outcome measured

Conditions

Gastric or Gastroesophageal Junction Adenocarcinoma

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NCT06841679

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AnYang Tumor Hospital

    Anyang, Chinano site contact published

    Recruiting

  • Bioresearch Partner

    Hialeah, Floridano site contact published

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Chinano site contact published

    Recruiting

  • Jinan Municipal Central Hospital

    Jinan, Chinano site contact published

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Chinano site contact published

    Recruiting

  • Shandong First Medical University Affiliated Tumor Hospital

    Jinan, Chinano site contact published

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Chinano site contact published

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Rongguo Qiu
[email protected]
010-56315388
Email the study team

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Eligibility criteria

Inclusion

Participants must meet the following criteria to be eligible for the study:
White blood cell count (WBC) ≥ 3.0 × 109/L;
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
Platelet count (PLT) ≥ 100 × 109/L;
Hemoglobin (Hb) ≥ 9.0 g/dL. 9. Participant with adequate liver and renal function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site).
Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);
Alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);
Aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);
Creatinine clearance (Ccr) ≥ 50 mL/min. 10. Female Participants of childbearing potential must agree to use highly effective contraceptive methods during the study and within 6 months after the last dose of the investigational product. Female patients of childbearing potential shall have a negative serum or urine pregnancy test at screening and be willing to have additional pregnancy tests as required throughout the study. Women of non-childbearing potential (WONCBP) must not donate ova from signing informed consent until at least 6 months after the last administration of the investigational product. Please refer to Appendix 1. Males must be surgically sterile (\> 6 months since vasectomy with confirmation of no viable sperm), or if engaged in sexual relations (intercourse) with a WOCBP, either his partner must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Screening until 6 months after last IMP administration; or Males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle; or Males must not donate sperm from the first dose of IMP until at least 90 days after the last dose of IMP.

Exclusion

Participants will be excluded from the study for any of the following reasons:
Patients with severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention or second/third-degree atrioventricular block; patients with a mean corrected QT interval (QTcF) \> 470 msec obtained from three 12-lead electrocardiograms (ECGs) at rest.
Patients who have had an acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardio-cerebrovascular events within 3 months before the first dose.
Patients with clinically uncontrollable hypertension.
Symptomatic Cerebral Infarction
Patients with other cardiac disorders that put the patients at a high risk as judged by the investigator. 17. Participants with uncontrolled diabetes mellitus. 18. Participants with a mental disorder or poor compliance. 19. Participants also participate in another interventional clinical study or receive other study treatments (patients who have discontinued other investigational treatments and are only in the follow-up period are allowed to be enrolled in this study). 20. Participants requiring concomitant use of strong CYP3A4 inhibitors or inducers or medications that prolong the QT interval within 14 days prior to the first dose of study treatment and during the study. 21. Participants with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.

What this trial measures

  • Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase IIFrom Day 1 to Day 21

    dose limiting toxicity (DLT), defined as any toxicity meeting the criteria outlined in the protocol during Cycle 1 in a 21-days cycle

  • Overall Survival (OS)12 months

    From the first dosing until death (from any cause), follow-up began after the end of treatment