Advanced gastric cancer
Conditions
Interventions
sacituzumab tirumotecan in combination with apatinib:sacituzumab tirumotecan in combination with apatinib
Sponsors
Yantai Yuhuangding Hospital
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.Histologically or pathologically confirmed adenocarcinoma of the stomach and gastroesophageal junction. 3.Previous failure of standard second - line systemic treatment. 4.For patients with brain metastases, those with asymptomatic or stable - symptomatic brain metastases are eligible for enrollment. 5.According to RECIST v1.1, at least one measurable target lesion should be identified by the investigator. 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 2. 7.Expected survival time >=12 weeks. 8.Adequate organ and bone marrow function. 9.For female subjects of child - bearing potential and male subjects whose partners have reproductive potential, effective medical contraceptive measures must be agreed to from the time of signing the informed consent form until 6 months after the last dose. 10.Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the visit and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1.Participated in other drug clinical trials within 4 weeks before enrollment. 2.Previously received apatinib or other anti - angiogenic drugs; those with imaging showing tumor invasion of major blood vessels, or those judged to be highly likely to have the tumor invade important blood vessels during the subsequent study period, leading to fatal massive hemorrhage; those with a tendency to bleed, such as acute gastrointestinal bleeding, persistent bleeding diseases, or coagulation disorders. 3.Those with multiple factors affecting oral drug intake (such as inability to swallow, post - gastrointestinal resection, chronic diarrhea, and intestinal obstruction, etc.). 4.Previously received treatment targeting TROP2 and/or treatment with topoisomerase I inhibitors. 5.Had other malignancies within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma. 6.Known history of allergy to the drugs in this protocol and their components. 7.Positive result in human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 8.History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 9.Received live vaccines within 30 days before the first study drug administration. 10.History of (non - infectious) interstitial lung disease (ILD) or non - infectious pneumonia requiring steroid treatment, currently having ILD or non - infectious pneumonia, or having suspicious ILD or non - infectious pneumonia that cannot be excluded by imaging examination at the time of screening; clinically severe lung damage caused by pulmonary comorbidities, including but not limited to any underlying pulmonary diseases (such as pulmonary embolism within 3 months before drug administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc.), or previous total pneumonectomy. 11.Suffering from active autoimmune diseases that required systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type I diabetes, hypothyroidism only requiring thyroxine replacement therapy, adrenal or pituitary insufficiency only requiring physiological - dose glucocorticoid replacement therapy). 12.Active infection requiring systemic treatment within 2 weeks before the first drug administration. 13.According to the investigator’s judgment, having concomitant diseases that seriously endanger the patient’s safety or affect the patient’s completion of the study, including but not limited to uncontrolled hypertension with drugs, severe diabetes, active infection, etc. 14.Documented severe dry eye syndrome, severe meibomian gland disease, and/or blepharitis, or history of corneal diseases that impede delayed corneal healing. 15.Pregnant or lactating female patients, female patients of child - bearing potential with a positive baseline pregnancy test, and female patients of child - bearing potential who are unwilling to take effective contraceptive measures during the treatment with the test drug and within 6 months after the last dose. 16.Any other conditions that, in the investigator’s opinion, make the patient unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;safety; | — |
Countries
China
Contacts
Public ContactJian Chen
Yantai Yuhuangding Hospital
Outcome results
None listed