Actively Recruiting
A Multicenter, Randomized, Controlled Phase III Clinical Study of Docetaxel for Injection (Albumin-bound) Versus Taxotere in Gastric Cancer
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-11-14
630
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
This trial is a phase III, multicenter, randomized, controlled study evaluating treatments for patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have experienced failure of first-line treatment. The study compares two chemotherapy drugs, Docetaxel for Injection (Albumin-bound) and Taxotere, to assess their effectiveness and safety in this patient population. Approximately 630 patients will be randomly assigned to receive either Docetaxel for Injection (Albumin-bound) or Taxotere. Both drugs will be given by intravenous infusion once every three weeks. Treatment will continue until the disease progresses. Regular visits and imaging scans will be conducted to monitor and compare the outcomes and side effects between the two treatment groups. Participants will have scheduled visits for imaging tests to assess tumor response and disease progression. Researchers will measure overall survival, tumor response rates, progression-free survival, disease control rates, duration of response, and the frequency and severity of any adverse events. Blood samples will be collected to analyze drug concentrations. The study will continue until disease progression, with ongoing monitoring to evaluate treatment effects and safety.
CONDITIONS
Brief 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 consent
- Diagnosis of gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction confirmed by tissue or cell analysis
- Locally advanced or metastatic disease that progressed after first-line platinum/fluorouracil-based chemotherapy, with or without immunotherapy
- Evidence of disease progression confirmed by imaging
- At least one measurable lesion not previously treated with radiotherapy or showing clear progression after radiotherapy
- Known Her-2 status and appropriate anti-Her-2 treatment if positive
- Adequate function of major organs
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival of at least 3 months
- Negative pregnancy test for women of childbearing age and agreement to use contraception; male participants must agree to contraception and not donate sperm
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- History of other active cancers within 5 years, except certain cured local tumors
- Uncontrolled fluid buildup requiring intervention within 14 days before enrollment
- Central nervous system metastases
- Previous treatment with paclitaxel or docetaxel unless progression occurred more than one year after prior treatment
- Deficient mismatch repair or high microsatellite instability status without prior immunotherapy
- Serious heart or blood vessel diseases, including serious arrhythmias, recent heart attack or stroke, poor heart function, long QTc interval, or uncontrolled high blood pressure
- History of gastrointestinal perforation or fistula in the past 6 months
- Active hepatitis B or C infection or HIV
- Severe infections needing systemic treatment within 14 days
- Tuberculosis treatment within 2 years
- Gastrointestinal obstruction or active inflammatory bowel disease within 28 days
- Unresolved severe side effects from previous treatments
- Recent major surgery or planned tumor surgery during the study
- Recent chemotherapy, immunotherapy, hormone therapy, targeted therapy, or experimental treatments within specified timeframes
- Recent use of strong CYP3A4 inhibitors or inducers
- Allergy or contraindication to albumin, docetaxel, or glucocorticoids
- Psychiatric or neurological disorders affecting study adherence or history of substance dependence
- Participation in another clinical trial unless observational or in follow-up
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive Docetaxel for Injection (Albumin-bound) or Taxotere by intravenous infusion every 3 weeks until disease progression.
Visits every 3 weeks corresponding with each treatment infusion
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
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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