A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
NCT ID: NCT05705635
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2023-01-13
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel for Injection (Albumin-bound)
Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.
Docetaxel for injection (Albumin-bound)
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
Taxotere
Taxotere will be administrated by intravenous infusion once every 3 weeks.
Taxotere
Taxotere, by intravenous infusion, every 3 weeks.
Interventions
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Docetaxel for injection (Albumin-bound)
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
Taxotere
Taxotere, by intravenous infusion, every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests.
3. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
4. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
5. Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
6. Adequate main organ function.
7. Eastern Cooperative Oncology Group (ECOG) score 0-1.
8. Expected lifetime≥ 3 months.
9. Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation.
10. At least one assessable lesion according to RECIST V1.1; The area should not have received radiotherapy in the past, or there is evidence that the lesion has made definite progress after radiotherapy.
Exclusion Criteria
2. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization.
3. Patients with central nervous system metastasis.
4. Patients whose previous medical history shows dMMR/MSI-H and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrolment.
5. Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel).
6. History of serious cardiovascular disease within 6 months before randomization.
7. History of gastrointestinal perforation and/or fistula within 6 months before randomization.
8. Hypertension with poor control during the screening period.
9. Patients with active hepatitis B, hepatitis C or HIV.
10. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy.
11. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.
12. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0).
13. Major organ surgery (except puncture biopsy) within 28 days before randomization.
14. Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization.
15. Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization.
16. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization.
17. Allergic to and / or contraindication to albumin or docetaxel.
18. Known allergy and/or contraindication to glucocorticoids.
19. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence / alcohol dependence.
20. Other situations that the researcher thinks are not suitable for participating in this study.
21. Patients participated in another clinical study at the same time, unless it is an observational (non intervention) clinical study or is in the follow-up period of an intervention study.
18 Years
75 Years
ALL
No
Sponsors
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruihua Xu
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
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Ethics Committee of Sun-Yat-Sen University Cancer Center
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Ruihua Xu
Role: primary
Other Identifiers
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HB1801-007
Identifier Type: -
Identifier Source: org_study_id