A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

Inclusion Criteria:

1. Age: 18-75 years (inclusive) (Whichever is on the day of signing the informedconsent form).

2. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmedby histology or cytology.

3. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma ofgastroesophageal junction that has progressed after receiving first-linesystematic treatment (defined as platinum/fluorouracil containing dual drugchemotherapy, with or without immunotherapy).

4. Evidence of disease progression on imaging during or after the last systemictreatment as confirmed by investigator.

5. At least one assessable lesion according to RECIST V1.1; the area should nothave received previous radiotherapy, or there should be evidence of definiteprogress 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 testwithin 7 days prior to randomization; patients must agree to take adequatecontraception from signing of ICF through 6 months after last dose, duringwhich time women are not breastfeeding; male patients must agree tocontraception and refuse sperm donation.

11. Fully understand this clinical trial and willing to sign a written informedconsent form.

Exclusion Criteria:

1. Medical history of other malignant tumors or other active malignant tumorswithin 5 years prior to randomization (cured local tumors, such as skin basalcell carcinoma, skin squamous cell carcinoma, superficial bladder cancer,prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma insitu, etc. can be included).

2. Uncontrolled serous cavity effusion requiring frequent drainage or medicalintervention within 14 days before randomization (Additional intervention isrequired within 2 weeks after intervention, such as pleural effusion, abdominaleffusion, pericardial effusion, etc., excluding exfoliative cytology testing ofexudate).

3. Patients with central nervous system metastasis.

4. Patients who have used paclitaxel/docetaxel in the past (except patients withdisease progression more than one year after neoadjuvant/adjuvant treatmentwith paclitaxel/docetaxel).

5. Patients whose previous medical history shows dMMR/MSI-H (deficient MismatchRepair or High Microsatellite Instability) and who have not receivedimmunotherapy in the past are not suitable for enrollment, and those whosedMMR/MSI status is unknown need to clarify the status before enrollment.

6. History of serious cardiovascular or cerebrovascular disease, including but notlimited to:

7. Serious cardiac rhythm or conduction abnormalities, such as ventriculararrhythmias requiring clinical intervention, third degree atrioventricularblock, etc;

8. Acute coronary syndrome, congestive heart failure, stroke, or other level 3 orhigher cardiovascular events occurring within 6 months before randomization;

9. The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ orleft ventricular ejection fraction (LVEF) of<50%;

10. Long QTc syndrome or QTc interval>480 milliseconds, as well as the use ofany known concomitant medication that can prolong the QT interval;

11. Poor control of hypertension (systolic blood pressure ≥ 160 mmHg and/ordiastolic blood pressure ≥ 100 mmHg during the screening period).

7. History of gastrointestinal perforation and/or fistula within 6 months beforerandomization.

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 testedpositive for HCV RNA by PCR) or HIV.

9. Patients with severe chronic or active infections that require systemicantimicrobial, antifungal, or antiviral therapy within 14 days beforerandomization. Note: Patients with viral hepatitis are allowed to receiveantiviral treatment.

10. Tuberculosis treatment history within 2 years before randomization.

11. Patients with gastrointestinal obstruction and active inflammatory boweldisease within 28 days before randomization.

12. Toxic reaction caused by any previous treatment has not recovered to level 1 orbelow (CTCAE5.0) (excluding anemia, alopecia, fatigue, poor appetite, or othertoxicities that the investigator deems to have no safety risk to patients).

13. Received major organ surgery or invasive intervention treatment within 28 daysbefore randomization. Or planned to undergo systematic or local tumor resectionsurgery during the study period.

14. Received intravenous chemotherapy or biopolymer therapy within 28 days beforerandomization. Or received oral chemotherapy, immunotherapy (such asinterleukin, interferon, thymosin, etc.), hormone therapy, small moleculetargeted therapy, or any experimental intervention within 14 days or 5half-lives (whichever is shorter) before randomization. Received traditionalChinese medicine or traditional Chinese patent medicines with anti-tumorindications within 14 days before randomization.

15. Have received powerful CYP3A4 inhibitor or inducer within 14 days beforerandomization.

16. Allergic to and/or contraindication to albumin or docetaxel.

17. Known allergy and/or contraindication to glucocorticoids (including but notlimited to active gastrointestinal ulcers, severe hypertension, severehypokalemia, glaucoma, etc).

18. Patients with psychiatric neurological disorders that may affect trialadherence, or patients with a history of drug dependence/alcohol dependence.

19. Patients participated in another clinical study at the same time, unless it isan observational (non-intervention) clinical study or is in the follow-upperiod of an intervention study.

20. Other situations that the investigator thinks are not suitable for patients inthis study.