gastric cancer
Conditions
Interventions
Test arm:Sacituzumab govitecan 4 mg/kg, intravenous infusion (IV), administered on Day 1 of each cycle (d1), every 2 weeks (Q2W).
Bevacizumab 5 mg/kg, intravenous infusion (IV), administered on Day 1
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years at the time of informed consent; either sex acceptable. 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal-junction adenocarcinoma (defined as tumours whose epicentre lies within 5 cm proximal and 5 cm distal to the gastro-oesophageal junction using the Siewert classification). 3. At least one measurable lesion per RECIST v1.1; lesions previously irradiated may not serve as target lesions. Participants with only skin or bone lesions are not eligible. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before dosing. 5. Prior first-line standard therapy for gastric cancer completed, or disease progression/recurrence within 6 months after completion of adjuvant systemic therapy. 6. Anticipated life expectancy > 12 weeks. 7. Adequate organ and bone-marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks before dosing): a. Haematology: absolute neutrophil count >= 1.2 × 10?/L; platelets >= 75 × 10?/L; haemoglobin >= 90 g/L. b. Hepatic: AST and ALT = 30 g/L; total bilirubin = 50 mL/min (Cockcroft–Gault formula). d. Coagulation: INR, aPTT and PT <= 1.5 × ULN. 8. Prior therapy-related acute toxicities recovered to grade <= 1 (alopecia and vitiligo excepted). Note: participants with any-grade endocrine adverse events may be enrolled if they are stable and asymptomatic on stable-dose hormone replacement. 9. Women of child-bearing potential and men with partners of child-bearing potential must agree to use effective medical contraception from informed consent until 6 months after the last dose (see Appendix 2). 10. Voluntary participation with written informed consent and ability to comply with protocol-mandated visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Known leptomeningeal, brain-stem or spinal-cord metastases and/or cord compression, or active CNS metastases. Participants with previously treated brain metastases may be enrolled if clinically stable >= 4 weeks before dosing and off corticosteroids and anticonvulsants >= 14 days. Untreated, asymptomatic brain metastases may be allowed at the investigator’s discretion. 2. Any other malignancy within 3 years before dosing, except adequately treated localised cancers (e.g., basal- or squamous-cell skin carcinoma, cervical carcinoma in situ). 3. Hypertension uncontrolled despite antihypertensive therapy (systolic >= 150 mmHg or diastolic >= 100 mmHg); grade >= 2 myocardial ischaemia, myocardial infarction, arrhythmia (including QTc >= 480 ms), NYHA class III–IV heart failure, or LVEF 325 mg/day), other anti-platelet NSAIDs, or ADP-receptor inhibitors (e.g., clopidogrel). History of GI bleeding from severe portal hypertension, active ulcer, ulcerative colitis, etc.; faecal occult blood >= "++". Coagulopathy: PT > 16 s, aPTT > 48 s, TT > 21 s, INR > 2, fibrinogen 10 mg/day prednisone or equivalent) within the past 2 years. Hormone-replacement therapy (thyroxine, insulin, physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy. Systemic corticosteroids > 10 mg/day or other immunosuppressants within 2 weeks before dosing. 14. Prior therapy with: a. TROP2-targeted agents; b. Topoisomerase I–targeted agents, including ADCs; c. Tumour vaccines or T-cell co-stimulatory modulators; d. Anti-angiogenic drugs. 15. Live vaccine within 30 days before dosing or planned live vaccine during the study. 16. Use of strong CYP3A4 inhibitors or inducers within 2 weeks before and during the study (see Appendix 7). Participants must avoid known CYP3A4-inducing drugs, herbal supp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall Survival (OS);Duration of Response (DoR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactWenfeng Li, Xiaochen Zhang
The First Affiliated Hospital of Wenzhou Medical University The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed