Gastric cancer
Conditions
Interventions
Experimental group:Sacituzumab tirumotecan Combined with Cadonilimab
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years at the time of signing the informed consent form, regardless of gender. 2.Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma). 3. Have received prior first-line systemic therapy (including chemotherapy and/or immunotherapy) and experienced radiologically confirmed disease progression during or after treatment. Patients who relapse within 6 months after completion of adjuvant therapy are eligible. 4.Have at least one measurable target lesion according to RECIST v1.1, as assessed by the investigator, that has not been previously irradiated. Eastern 5.Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6.Expected survival >= 12 weeks. 7.Adequate organ and bone marrow function (without transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: a) Hematology: absolute neutrophil count (ANC) >= 1.5 × 10?/L;platelet count (PLT) >= 100 × 10?/L;.hemoglobin (Hb) >= 90 g/L. b) 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). d) Coagulation: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5 × ULN. 8.For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose. 9.The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with the protocol-specified visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Histopathological examination confirms other pathological types, such as squamous cell carcinoma, sarcoma or anaplastic carcinoma. 2. Participated in other drug clinical trials within 4 weeks before enrollment. 3. Previous use of TROP2-targeted therapy and/or topoisomerase I inhibitors. 4. Other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, basal carcinoma of the skin, or squamous cell carcinoma of the skin. 5. Known history of allergy to the drugs and components of this regimen. 6. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection. 7. Active autoimmune disease requiring systemic therapy within 2 years prior to the start of study treatment, or presence of autoimmune disease that may recur or be planned for treatment in the judgment of the investigator. 8. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 9. Live vaccine vaccination within 30 days prior to the first study administration. 10. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy, current ILD or non-infectious pneumonitis, or suspicious ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; Clinically severe lung impairment due to pulmonary intercurrent diseases, including but not limited to any underlying pulmonary disease (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc.) within 3 months prior to dosing, or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy. 11. Active autoimmune disease that has required systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type I diabetes mellitus, hypothyroidism requiring thyroxine replacement therapy, adrenal or pituitary insufficiency requiring physiological dose 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 concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study, including but not limited to hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc. 14. Documented severe dry eye syndrome, severe meibomian gland disease, and/or blepharitis, or presence of a history of corneal disease that precludes delayed corneal healing. 15. Pregnant and lactating female patients, female patients of childbearing potential with positive baseline pregnancy test, and female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial drug treatment and within 6 months of the last dose of drug. 16. Any other condition that the investigator believes the patient is not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactTianshu Liu
Zhongshan Hospital, Fudan University
Outcome results
None listed