Clinical trial for Gastric Cancer
Official title A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
ClinicalTrials.gov ID: NCT06296706
What this study is testing
What is Docetaxel for injection (Albumin-bound)?
Docetaxel for injection (Albumin-bound) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Also referred to as HB1801.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- 1\. Medical history of other malignant tumors or other active malignant tumors within 5 years prior to randomization (cured local tumors, such as...
- 2\. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 14 days before randomization (Additional...
- 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...
- 5\. Patients whose previous medical history shows dMMR/MSI-H (deficient Mismatch Repair or High Microsatellite Instability) and who have not received...
- 6\. History of serious cardiovascular or cerebrovascular disease, including but not limited to:
See the full eligibility criteria
Who can join
- 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...
- 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...
- 11\. Fully understand this clinical trial and willing to sign a written informed consent form.
What rules you out
- 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...
- 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...
- 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...
- 6\. History of serious cardiovascular or cerebrovascular disease, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc;
- Acute coronary syndrome, congestive heart failure, stroke, or other level 3 or higher cardiovascular events occurring within 6 months before randomization;
- The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of\<50%;
- Long QTc syndrome or QTc interval\>480 milliseconds, as well as the use of any known concomitant medication that can prolong the QT interval;
- 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)...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.