Actively Recruiting
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Beijing Biostar Pharmaceuticals Co., Ltd. · Updated on 2025-11-25
778
Participants Needed
10
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.
CONDITIONS
Official Title
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign informed consent and agree to follow the study protocol.
- Male or female aged 18 years or older.
- Have unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology.
- For phase III, tumor PD-L1 Combined Positive Score (CPS) less than 1; no PD-L1 restriction for phase II.
- Have at least one measurable tumor lesion per RECIST 1.1.
- No prior systemic treatment for advanced disease; prior neoadjuvant/adjuvant therapy allowed if completed over 6 months ago.
- ECOG performance status of 0 or 1.
- Adequate blood counts within 1 week before enrollment and no recent use of growth factors or blood products.
- Adequate liver and kidney function within 1 week before enrollment.
- Female participants of childbearing potential must use effective contraception and have negative pregnancy tests; males must use contraception or meet sterilization requirements as specified.
You will not qualify if you...
- Known HER2-positive tumor status.
- Other malignancies in the past 5 years, except certain cured cancers.
- Radiotherapy or investigational therapy within 4 weeks prior to first study dose.
- Major surgery or significant trauma within 4 weeks prior to first dose or planned surgery during study.
- Pre-existing peripheral sensory neuropathy greater than grade 1.
- Known allergy to any study drug components.
- Pregnant or breastfeeding women.
- Unresolved adverse events from prior anti-tumor therapy above grade 1 (except alopecia).
- Difficulty swallowing or unable to take oral medications.
- Symptomatic or uncontrolled brain or meningeal metastases.
- Uncontrolled bone metastases or recent fractures requiring intervention.
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage.
- Active infection requiring systemic treatment.
- Known HIV infection unless no opportunistic infection in past year.
- Positive for HBV DNA or HCV RNA (with some exceptions).
- Severe cardiovascular or cerebrovascular disease including recent heart attack or stroke, uncontrolled hypertension, or high-risk cardiac disorders.
- Uncontrolled diabetes.
- Mental disorder or poor compliance.
- Participation in another interventional clinical study or treatment.
- Use of strong CYP3A4 inhibitors/inducers or QT prolonging drugs within 14 days before first dose or during study.
- Other severe systemic diseases or abnormal labs deemed inappropriate by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Bioresearch Partner
Hialeah, Florida, United States, 33013
Not Yet Recruiting
2
AnYang Tumor Hospital
Anyang, China
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
4
Jinan Municipal Central Hospital
Jinan, China
Actively Recruiting
5
Shandong First Medical University Affiliated Tumor Hospital
Jinan, China
Actively Recruiting
6
Liaoning Cancer Hospital
Shenyang, China
Actively Recruiting
7
Shanxi Cancer Hospital
Taiyuan, China
Not Yet Recruiting
8
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Not Yet Recruiting
9
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Not Yet Recruiting
10
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
R
Rongguo Qiu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here