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Trial Title:
A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
NCT ID:
NCT06296706
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Docetaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel for injection (Albumin-bound)
Description:
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks
Arm group label:
Docetaxel for Injection (Albumin-bound)
Other name:
HB1801
Intervention type:
Drug
Intervention name:
Taxotere (docetaxel)
Description:
Taxotere, by intravenous infusion, every 3 weeks.
Arm group label:
Taxotere (Docetaxel)
Other name:
Taxotere
Summary:
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.
Detailed description:
About 630 patients with locally advanced or metastatic gastric adenocarcinoma or gastric
esophageal junction adenocarcinoma will be randomly assigned to the test group or the
control group. All patients will receive Docetaxel for injection (Albumin-bound) or
Taxotere for treatment until disease progression. Regular visits and imaging examinations
will be conducted to compare the efficacy and safety of the two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-75 years (inclusive) (Whichever is on the day of signing the informed
consent form).
2. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by
histology or cytology.
3. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of
gastroesophageal junction that has progressed after receiving first-line systematic
treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with
or without immunotherapy).
4. Evidence of disease progression on imaging during or after the last systemic
treatment as confirmed by investigator.
5. At least one assessable lesion according to RECIST V1.1; the area should not have
received previous radiotherapy, or there should be evidence of definite progress of
the lesion after completion of radiotherapy.
6. Previous history with positive Her-2 expression requires anti-Her-2 medication;
unknown Her-2 expression should define Her-2 status before enrollment.
7. Adequate main organ function.
8. Eastern Cooperative Oncology Group (ECOG) score 0-1.
9. Expected lifetime≥ 3 months.
10. 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.
11. Fully understand this clinical trial and willing to sign a written informed consent
form.
Exclusion Criteria:
1. Medical history of other malignant tumors or other active malignant tumors within 5
years prior to randomization (cured local tumors, such as skin basal cell carcinoma,
skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in
situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included).
2. Uncontrolled serous cavity effusion requiring frequent drainage or medical
intervention within 14 days before randomization (Additional intervention is
required within 2 weeks after intervention, such as pleural effusion, abdominal
effusion, pericardial effusion, etc., excluding exfoliative cytology testing of
exudate).
3. Patients with central nervous system metastasis.
4. 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).
5. Patients whose previous medical history shows dMMR/MSI-H (deficient Mismatch Repair
or High Microsatellite Instability) 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 enrollment.
6. History of serious cardiovascular or cerebrovascular disease, including but not
limited to:
1) Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias
requiring clinical intervention, third degree atrioventricular block, etc; 2) Acute
coronary syndrome, congestive heart failure, stroke, or other level 3 or higher
cardiovascular events occurring within 6 months before randomization; 3) The New
York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular
ejection fraction (LVEF) of<50%; 4) Long QTc syndrome or QTc interval>480
milliseconds, as well as the use of any known concomitant medication that can
prolong the QT interval; 5) Poor control of hypertension (systolic blood pressure ≥
160 mmHg and/or diastolic blood pressure ≥ 100 mmHg during the screening period).
7. History of gastrointestinal perforation and/or fistula within 6 months before
randomization.
8. Patients with active hepatitis B(Hepatitis B surface antigen (HBsAg) or HBcAb
positive, and in the active phase of hepatitis B (HBV-DNA ≥ 10^4 cps/mL or ≥ 2000
IU/mL)), hepatitis C(Hepatitis C antibody (Anti HCV) positive and tested positive
for HCV RNA by PCR) or HIV.
9. Patients with severe chronic or active infections that require systemic
antimicrobial, antifungal, or antiviral therapy within 14 days before randomization.
Note: Patients with viral hepatitis are allowed to receive antiviral treatment.
10. Tuberculosis treatment history within 2 years before randomization. 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) (excluding anemia, alopecia, fatigue, poor appetite, or other
toxicities that the investigator deems to have no safety risk to patients).
13. Received major organ surgery or invasive intervention treatment within 28 days
before randomization. Or planned to undergo systematic or local tumor resection
surgery during the study period.
14. Received intravenous chemotherapy or biopolymer therapy within 28 days before
randomization. Or received oral chemotherapy, immunotherapy (such as interleukin,
interferon, thymosin, etc.), hormone therapy, small molecule targeted therapy, or
any experimental intervention within 14 days or 5 half-lives (whichever is shorter)
before the first treatment. Received traditional Chinese medicine or traditional
Chinese patent medicines with anti-tumor indications within 14 days before
randomization.
15. Have received powerful CYP3A4 inhibitor or inducer within 14 days before
randomization.
16. Allergic to and/or contraindication to albumin or docetaxel. 17. Known allergy
and/or contraindication to glucocorticoids (including but not limited to active
gastrointestinal ulcers, severe hypertension, severe hypokalemia, glaucoma, etc).
18. Patients with psychiatric neurological disorders that may affect trial adherence, or
patients with a history of drug dependence/alcohol dependence.
19. 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.
20. Other situations that the investigator thinks are not suitable for patients in this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CSPC Zhongqi Technology(SJZ) Ltd
Address:
City:
Shijiazhuang
Zip:
050035
Country:
China
Start date:
March 1, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06296706