Advanced gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Study Arm:Tuvonralimab/Iparomlimab with paclitaxel, albumin?bound paclitaxel, or paclitaxel liposome
Sponsors
Foshan Nanhai District People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years (including 18 years), of either sex. 2. Histologically and/or cytologically confirmed metastatic or unresectable advanced gastric or gastroesophageal junction adenocarcinoma. 3. Failure of prior first-line standard regimen therapy. 4. All toxicities (excluding alopecia) related to prior chemotherapy, surgery, radiotherapy, or immunotherapy have resolved to 1.5×10?/L; • Hemoglobin (HGB) >90 g/L; • Platelet count (PLT) >100×10?/L. b) Coagulation (without blood product transfusion within 14 days prior to treatment): • International normalized ratio (INR) or prothrombin time (PT) =50 mL/min; • Total bilirubin (TBIL) 2.7 g/dL. 9. Urine protein =6 months, as assessed by the investigator. 11. Ability to provide written informed consent (ICF) and understand and agree to comply with the study requirements and scheduled assessments. 12. Female patients must be surgically sterile, postmenopausal, or willing to use a highly effective method of contraception during the treatment period and for 12 weeks after the last dose; male patients must be surgically sterile or willing to use a highly effective method of contraception during the treatment period and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Known HER2-positive status (defined as IHC 3+ or IHC 2+ with ERBB2 gene amplification). 2. Prior treatment with taxane-based therapy. 3. Received systemic therapy (including chemotherapy, immunotherapy, or targeted therapy) or local therapy (including surgery or radiotherapy) for advanced disease within 14 days before enrollment. 4. Hypertension that cannot be controlled by medication (systolic blood pressure =160 mmHg and diastolic blood pressure >=90 mmHg). 5. Brain metastases, carcinomatous meningitis, spinal cord compression, or evidence of cerebral or leptomeningeal disease on CT or MRI at screening. 6. Refractory pleural effusion or ascites requiring puncture drainage within 2 weeks before the first dose. 7. History of other malignancies, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors (Ta, Tis, and T1). 8. Allergy to any study drug or excipient. 9. Chronic hepatitis B or hepatitis B virus (HBV) carriers with HBV DNA >500 IU/mL, or active hepatitis C virus (HCV) infection. 10. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or other conditions assessed by the investigator as potentially affecting study treatment. 11. Long-term use of high-dose corticosteroids or other immunomodulators. 12. Active infection. 13. Received live or attenuated vaccine within 30 days before the first dose, or planned to receive such vaccine during the study period (excluding COVID-19 vaccine). 14. Occurrence of arterial or venous thrombotic events within 6 months, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism. 15. Severe cardiovascular disease: myocardial ischemia or myocardial infarction of Grade II or higher, or stent implantation within 6 months before enrollment; uncontrolled arrhythmia; New York Heart Association (NYHA) class III–IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography. 16. History of interstitial lung disease or uncontrolled systemic diseases, including diabetes mellitus, acute lung disease, etc. 17. Known human immunodeficiency virus (HIV) infection. 18. Major surgery requiring general anesthesia within <=28 days before the first dose. 19. Presence of underlying medical conditions, or alcohol/drug abuse or dependence, that may interfere with study drug administration, affect interpretation of results, or place the patient at high risk of treatment complications. 20. Already enrolled in other therapeutic clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactWei Zeng
Foshan Nanhai District People's Hospital
Outcome results
None listed