Gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Injection, regorafenib, and paclitaxel injection
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this trial: 1. Age >=18 years old and =10 mm, CT scan short diameter of lymph node lesions >=15 mm); 4. Previous first-line treatment with fluoropyrimidine, platinum and immune checkpoint inhibitors (including PD1/PDL1 inhibitors) has failed and disease progression within 6 months; 5. Eastern Cooperative Oncology Group (ECOG) physical status score 0-2; 6. Expected survival time>=3 months; 7. No dysfunction of major organs, that is, the subject's organ function level and related laboratory indicators must meet the following requirements within 14 days before starting study treatment: (1) Blood routine (no blood transfusion, platelet transfusion, growth factor and other supportive therapy within 14 days before starting study treatment): white blood cell (WBC) >=3.0×109/L; Absolute neutrophil count (ANC) >=1.5×109/L; Platelet count (PLT) >=100×109/L; Hemoglobin (Hb) >=90 g/L (2) Blood biochemistry: serum albumin (ALB) >=30 g/L; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =60 mL/min (3) Urine routine: Urine routine suggests urine protein =++ at baseline, it is necessary to confirm that the 24-hour urine protein quantitative = low limit of normal (i.e., LVEF>=50%); 8. Other anti-tumor treatments received in the past need to end treatment for 4 weeks or more, and the general physical condition or related adverse reactions have recovered (toxicity <=grade 1) or reached a stable state; 9. The serum pregnancy test of women of childbearing age must be negative within 7 days before starting study treatment, and must be non-lactating; Female subjects of childbearing potential or male subjects whose partners are women of childbearing potential must agree to use medically permitted contraception (e.g., intrauterine device, male surgical sterilization, birth control pills, or condoms) during the trial and for 6 months after the end of the study treatment period; 10. Volu
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be admitted to this study: 1. Previous malignant tumors other than gastric cancer and adenocarcinoma of the gastroesophageal junction within 5 years before screening (except for cured basal cell or squamous epithelial cell carcinoma of the skin, carcinoma in situ of the cervix, and malignant tumors with low-risk metastasis and death risk assessed by the investigator); 2. Intolerance to first-line standard therapy combined with fluoropyrimidine, platinum, and immune checkpoint inhibitors (including PD1/PDL1 inhibitors); 3. Known tumor tissue confirmed by immunohistochemistry as mismatch repair deficiency (dMMR) state, or microsatellite high instability (MSI-H) confirmed by next-generation sequencing (NGS)/polymerase chain reaction (PCR) method, and is evaluated by the investigator to be suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors); 4. Known HER2-positive gastric and gastroesophageal junction adenocarcinoma (immunohistochemistry 3+ or 2+/FISH amplification positive); 5. For patients with known central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced electronic computed tomography (CT) or enhanced magnetic resonance (MRI) examination must be performed within 28 days before starting study treatment to rule out central nervous system metastasis; 6. Previous treatment of paclitaxel, small molecule multi-target antivascular drugs, CTLA4 inhibitors or immune bispecific antibodies; 7. Use of strong inhibitors/strong inducers of CYP3A4, CYP2C8 and UGT1A1 within 14 days before starting study drugs; 8. Participated in other drug clinical trials within 4 weeks before starting study treatment; 9. Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; NCI-CTCAE v5.0 > grade 2 inflammation; NCI-CTCAE v5.0 >grade 1 diarrhea), or other conditions that may affect drug intake, transport or absorption as judged by the investigator (including inability to swallow; After small bowel resection or total gastrectomy, etc.); 10. Pleural effusion or peritoneal effusion requiring clinical intervention (NCI-CTCAE v5.0>=grade 2); 11. Presence of serious comorbidities, active infection, or uncontrolled diabetes that would preclude treatment with the trial drug: (1) Uncontrolled serious medical diseases that the investigator believes will affect the subject's ability to receive treatment under the study protocol, such as complicated serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; (2) Arterial/venous thrombotic events within one year prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization due to previous chemotherapy and judged to have been cured by the investigator), and pulmonary embolism, etc.; (3) Imaging shows that the tumor has invaded the periphery of important blood vessels, or the investigator judges that the patient's tumor is very likely to invade important blood vessels during treatment, causing fatal hemorrhage; (4) Subjects have active, known or suspected autoimmune diseases, including systemic lupus erythematosus, Hashimoto's thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis; Subjects with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;progression free survival;Disease control rate;security; | — |
Countries
China
Contacts
Public ContactLi Shen
Jiangsu Cancer Hospital
Outcome results
None listed