Advanced Gastric cancer
Conditions
Interventions
Experimental group:Sacituzumab Tirumotecan Combined With Anlotinib
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years at the time of signing the informed consent form, gender not restricted; 2.Pathologically or histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction; 3.Previous failure of first-line systemic therapy containing oxaliplatin and fluoropyrimidine, or failure of first-line immunotherapy. 4.For patients with brain metastases, asymptomatic or those with stable symptoms from brain metastases are eligible for enrollment; 5.At least one measurable target lesion as assessed by the investigator according to RECist v1.1; 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 7.Life expectancy >= 12 weeks; 8.Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: (1) Hematology: Neutrophil count (NEUT#) >= 1.5 × 10^9/L; Platelets (PLT) >= 100 × 10^9/L; Hemoglobin >= 90 g/L; (2) Liver function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 30 g/L; Total Bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); (4) Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) <= 1.5 × ULN; 9.For female subjects of childbearing potential and male subjects whose partners are of childbearing potential, they must agree to use effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose; 10.Subjects voluntarily agree to participate in the study, sign the informed consent form, and are able to comply with the study visits and related procedures as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1.Participated in another clinical trial of drugs within 4 weeks prior to enrollment. 2.Previous receipt of anlotinib or other anti-angiogenic drugs; patients with tumor invasion of large blood vessels as shown by imaging, or those judged to be at high risk of fatal massive hemorrhage due to tumor invasion of important blood vessels during the subsequent study period; patients with a bleeding tendency such as acute gastrointestinal bleeding, continuous bleeding disorders, or coagulation dysfunction. 3.Presence of multiple factors affecting oral drug administration (e.g., inability to swallow, post-gastrointestinal resection surgery, chronic diarrhea, intestinal obstruction, etc.). 4.Previous treatment with TROP2-targeted therapy and/or topoisomerase I inhibitor therapy. 5.History of other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 6.Known history of allergy to the drugs in this protocol or their components. 7.Positive Human Immunodeficiency Virus (HIV) test or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection. 8.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9.Vaccination with a live vaccine within 30 days prior to the first study drug administration. 10.History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia at screening that cannot be excluded by imaging; clinically significant lung damage caused by concurrent lung diseases, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or previous pneumonectomy. 11.History of active autoimmune diseases requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., type I diabetes, hypothyroidism requiring only thyroxine replacement therapy, adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy). 12.Active infection requiring systemic treatment within 2 weeks prior to the first dose. 13.According to the investigator's judgment, there are serious concurrent diseases that endanger patient safety or affect the patient's completion of the study, including but not limited to poorly controlled hypertension, severe diabetes, active infections, etc. 14.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that impede or delay corneal healing. 15.Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, and female patients of childbearing potential who are unwilling to use effective contraceptive measures during the study drug treatment period and for 6 months after the last dose. 16.Any other conditions deemed by the investigator to make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease Control Rate (DCR);Duration of Response (DOR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactYongxu Jia
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed