Stomach cancer or cancer of the gastroesophageal junction
Conditions
Interventions
Test group:The patient will receive treatment with lucatumumab (4mg/kg, IV d1 Q2W) and toripalimab (3mg/kg, IV d1 Q2W).
Sponsors
Huadong Hospital Affiliated to 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, with no gender restrictions. 2. Histopathologically confirmed unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma). 3. Previously received first-line systemic treatment with immune checkpoint inhibitors in combination with chemotherapy, and experienced disease progression confirmed by imaging during or after treatment. 4. At least one measurable target lesion that has not been treated with radiotherapy, as assessed by the investigator according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 6. Expected survival >= 12 weeks. 7. Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor treatment within 2 weeks before the first dose), defined as follows: a) Blood routine: Neutrophil count (NEUT#) >= 1.5×10^9/L; platelet (PLT) >= 100×10^9/L; hemoglobin >= 80g/L; b) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30g/L; total bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); d) Coagulation function: 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, effective medical contraceptive measures must be agreed upon from the time of signing the informed consent form until 6 months after the last dose. 9. Subjects voluntarily join this study, sign the informed consent form, and are able to comply with the visit schedule and related procedures as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Pathological histological examination confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma, etc. 2. Participated in other drug clinical trials within 4 weeks before enrollment. 3. Previously used TROP2-targeted therapy and/or topoisomerase I inhibitors. 4. Experienced any of the following situations during first-line treatment with PD-1/PD-L1 inhibitors: a. Progression within 3 months after treatment initiation; b. Previously experienced grade 3 or higher adverse reactions caused by PD-1/PD-L1 inhibitors, grade 2 immune-related cardiotoxicity, or any grade of neurological or ocular adverse reactions; c. All adverse events from previous PD-1/PD-L1 inhibitor treatment had not been completely resolved or had not been reduced to grade 1 before the screening of this study; d. Previously experienced adverse events requiring treatment with immunosuppressants other than glucocorticoids. 5. Had other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 6. Known to have an allergy history to the drugs in this protocol and their components. 7. Positive for human immunodeficiency virus (HIV) or with a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection. 8. Active autoimmune diseases requiring systemic treatment within 2 years before the start of study treatment, or the investigator judged that there was a possibility of recurrence or planned treatment of autoimmune diseases. 9. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 10. Received live vaccines within 30 days before the first study administration. 11. Had a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently had ILD or non-infectious pneumonia, or had suspicious ILD or non-infectious pneumonia that could not be excluded by imaging at the time of screening; clinically significant lung damage due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary diseases (such as pulmonary embolism within 3 months before 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 (such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy. 12. Had active autoimmune diseases requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy). 13. Had active infections requiring systemic treatment within 2 weeks before the first administration. 14. According to the investigator's judgment, had serious concomitant diseases that could endanger the patient's safety or affect the patient's completion of the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc. 15. Had a history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or had a history of corneal diseases that could impede delayed corneal healing. 16. Pregnant or lactating women,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);progression-free survival (PFS);disease control rate (DCR) ;duration of response (DOR) ; | — |
Countries
China
Contacts
Public ContactTang Xi
Huadong Hospital Affiliated to Fudan University
Outcome results
None listed