Gastric-type adenocarcinoma of the cervix
Conditions
Interventions
Experimental group:Sacituzumab tritumotecan combined with Iparomlimab and Tuvonralimab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old at the time of signing the informed consent form, female; 2. Based on the pathological report of recent biopsy or other pathological specimens, the histological diagnosis was cervical gastric adenocarcinoma. 3. Recurrence / metastasis or uncontrolled cervical gastric adenocarcinoma, disease progression during or after platinum-based systemic therapy ( with or without bevacizumab ), or previous or no anti-PD-1 / PD-L1 therapy during or after platinum-based systemic therapy. 4. The Eastern Cooperative Oncology Group ( ECOG ) physical status score was 0 or 1. 5. According to RECIST 1.1, patients must have measurable disease ; measurable lesions were defined as lesions that could be accurately measured in at least one dimension ( the longest diameter recorded by computed tomography ( CT ) scan and magnetic resonance imaging ( MRI ) was >= 10 mm ; the short axis of the lymph node must be >= 15 mm. 6. Expected survival >= 12 weeks. 7. Have sufficient organ function and bone marrow function ( no blood transfusion, recombinant human thrombopoietin or colony stimulating factor treatment within 2 weeks before the first administration ) : a. blood routine : neutrophil count ( NEUT # ) >= 1.2 × 10^9 / L ; platelet ( PLT ) >= 90 × 10^9 / L ; b. liver function : aspartate aminotransferase ( AST ), alanine aminotransferase ( ALT ) <= 3 × upper limit of normal ( ULN ) ; c. Coagulation function : international normalized ratio ( INR ), activated partial thromboplastin time ( APTT ) and prothrombin time ( PT ) <= 1.5 × ULN. 8. For female subjects with fertility, those who have taken effective medical contraceptive measures within 6 months after the last administration from the time of signing the informed consent to the time of the last administration. 9. The subjects volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with other malignant tumors known to be progressing or requiring active treatment in the past 5 years. Except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin or cervical cancer in situ that has received potentially curative treatment. 2. The manifestations were secondary or higher grade myocardial ischemia, myocardial infarction, arrhythmia ( including QT interval >= 480ms ), and cardiac function classification was NYHA III-IV. 3. There is a history of gastrointestinal bleeding due to severe portal hypertension or a clear tendency to such. Or for other reasons ( such as active ulcer, ulcerative colitis, etc. ) there is a clear tendency of gastrointestinal bleeding. 4. Subjects known to have allergic or hypersensitivity reactions to research drugs or excipients; 5. Subjects who had previously been treated with TROP2 ADC drugs or with topoisomerase I inhibitor ADC were enrolled. 6. He has previously received double immunotherapy ( targeting both PD-1 / L1 and CTLA-4 ). 7. Patients with current or previous history of severe antibody drug allergy ; any disease requiring systemic treatment with corticosteroids ( daily dose of prednisone or equivalent drugs > 10mg ) or other immunosuppressive drugs was experienced within 14 days before enrollment. The use of topical alternative steroids ( daily doses of <= 10 mg of prednisone or equivalent drugs ) and prescription corticosteroids for short-term ( <= 7 days ) prophylaxis or for the treatment of non-autoimmune diseases is permitted. Have any active autoimmune disease or autoimmune history. 8. A history of active autoimmune diseases or autoimmune diseases that may recur. Inclusion is permitted for well-controlled type I diabetes, hypothyroidism requiring only hormone replacement therapy, well-controlled celiac disease, skin diseases that do not require systemic treatment ( such as vitiligo, psoriasis, or alopecia ), or diseases that are not expected to recur without external causes. 9. Current or previous history of interstitial lung disease or pulmonary fibrosis ( according to imaging or clinical diagnosis ). If the patient had a history of radiation pneumonitis, but had been confirmed to be in a stable condition ( had passed the acute phase ) and had no risk of recurrence, the patient could be included in the group. 10. Subjects with active hepatitis B ( defined as positive hepatitis B virus surface antigen [ HBsAg ] test results during screening and HBV-DNA detection values higher than the upper limit of the normal value of the laboratory in the research center ) or hepatitis C ( defined as positive hepatitis C virus surface antibody [ HCsAb ] test results during screening and HCV-RNA positive ). 11. Known human immunodeficiency virus ( HIV ) infection ( known HIV antibody positive ); 12. Live vaccine was inoculated within 30 days before the first administration. This includes, but is not limited to, the following : mumps, rubella, measles, varicella / herpes zoster ( varicella ), yellow fever, rabies, BCG and typhoid vaccines ( inactivated virus vaccine permitted ); 13. Patients currently suffering from diverticulitis or symptomatic gastrointestinal ulcer disease. 14. Patients with pericardial effusion, pleural effusion or ascites who need treatment; 15. Patients with uncontrollable tumor-related pain; 16. Patients who had transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism ( such as pulmonary embolism or deep vein thrombos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event (AE);Physical Examination;Eastern Cooperative Oncology Group Performance Status (ECOG PS);Progression-Free Survival (PFS);Virology Laboratory Tests;12-Lead Electrocardiogram (12-Lead ECG);Treatment-Emergent Adverse Event (TEAE);Duration of Response (DOR);Vital Signs;Thyroid Function Tests;Coagulation Laboratory Parameters;Time To Response (TTR);Cardiac Enzyme Panel;Urinalysis;Overall Survival (OS);Disease Control Rate (DCR);Serious Adverse Event (SAE);Hematology Laboratory Parameters;Serum Chemistry Laboratory Parameters;Pregnancy Test; | — |
Countries
China
Contacts
Public ContactTao Zhu
Zhejiang Cancer Hospital
Outcome results
None listed