Actively Recruiting
A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-11-14
630
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.
CONDITIONS
Official Title
A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years (inclusive) at the time of signing consent
- Histologically or cytologically confirmed gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction
- Locally advanced or metastatic disease progressed after first-line platinum/fluorouracil based chemotherapy, with or without immunotherapy
- Disease progression confirmed by imaging during or after last systemic treatment
- At least one measurable lesion by RECIST V1.1 not previously irradiated or showing progression after radiotherapy
- Positive Her-2 expression patients must have received anti-Her-2 therapy; unknown status must be determined before enrollment
- Adequate function of main organs
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before randomization and agree to use contraception through 6 months after last dose; males must agree to contraception and avoid sperm donation
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- History of other active malignancies within 5 years (except certain cured local tumors like skin basal cell carcinoma, in situ carcinomas)
- Uncontrolled serous cavity effusion requiring frequent drainage or intervention within 14 days before randomization
- Central nervous system metastases
- Prior use of paclitaxel or docetaxel unless progression occurred more than 1 year after neoadjuvant/adjuvant treatment
- Known dMMR/MSI-H status without prior immunotherapy; unknown status must be clarified before enrollment
- Serious cardiovascular or cerebrovascular disease including significant arrhythmias, recent major cardiac events, NYHA class II or higher, low LVEF, prolonged QTc interval, or poorly controlled hypertension
- History of gastrointestinal perforation or fistula within 6 months before randomization
- Active hepatitis B, hepatitis C, or HIV infection
- Severe infections requiring systemic antimicrobial therapy within 14 days
- Tuberculosis treatment within 2 years
- Gastrointestinal obstruction or active inflammatory bowel disease within 28 days
- Unresolved toxicities from prior treatments above grade 1 (except some non-safety risks)
- Major surgery or invasive intervention within 28 days or planned tumor resection during study
- Recent chemotherapy, immunotherapy, hormone therapy, targeted therapy, or experimental treatments within specified washout periods
- Use of strong CYP3A4 inhibitors or inducers within 14 days
- Allergy or contraindication to albumin, docetaxel, or glucocorticoids
- Psychiatric or neurological disorders affecting adherence or history of drug/alcohol dependence
- Participation in other interventional clinical trials concurrently
- Other investigator-determined factors making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
CSPC Zhongqi Technology(SJZ) Ltd
Shijiazhuang, Hebei, China, 050035
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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