Esophageal squamous cell carcinoma (ESCC)
Conditions
Interventions
Experimental group:Vibecotuotamab combined with tislelizumab plus chemotherapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older; 2. Male or non-pregnant, non-lactating female; 3. ECOG score of 0-1, with no deterioration within the past 7 days; 4. Patients with histologically confirmed locally advanced or metastatic esophageal squamous cell carcinoma; 5. No prior systemic treatment for this type of cancer; patients who have received neoadjuvant or adjuvant therapy must show disease progression or recurrence at least 6 months after completing treatment; 6. Metastatic patients must have measurable lesions according to RECIST 1.1; patients undergoing neoadjuvant therapy must have assessable lesions; 7. Adequate organ and bone marrow function with lab results meeting the following: (1) HGB >= 90 g/L; (2) NEUT >= 1.5 × 10^9/L; (3) PLT >= 80 × 10^9/L; (4) TBIL = 50 ml/min (Cockcroft-Gault formula); (7) Proteinuria < ( ), or 24-hour urine protein < 1.0 g; 8. Normal coagulation function and no active bleeding: (1) INR <= 1.5; (2) APTT <= 1.5 × ULN; 9. Women of childbearing potential must test negative for pregnancy (blood or urine) within 14 days before enrollment and agree to use adequate contraception during the study and for 8 weeks after the last study drug; men must be surgically sterile or agree to use adequate contraception during the study and for 8 weeks after the last study drug; 10. Expected survival of 6 months or more; 11. Patients voluntarily agree to join the study and have signed the informed consent form (ICF); 12. Expected to comply well, able to follow up on treatment efficacy and adverse events as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Previously received any anti-EGFR monoclonal antibody treatment or anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies acting on T-cell co-stimulation or checkpoint pathways; 2. Received a live vaccine within 4 weeks before enrollment or expected to receive one during the study; 3. Had active autoimmune disease or a history of autoimmune disease within 4 weeks before enrollment; 4. Previously had allogeneic bone marrow or organ transplantation; 5. Had uncontrolled high blood pressure before enrollment, defined as: systolic >=160 mmHg and/or diastolic >=90 mmHg; 6. Had any condition affecting drug absorption before enrollment; 7. Had clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months before enrollment; congestive heart failure NYHA class >2; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) =CTCAE v5.0 grade 2); 9. Known HIV infection. Known clinically significant liver disease history, including viral hepatitis [known HBV carriers must exclude active HBV infection, i.e., HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL); known HCV infection with HCV RNA positive (>1×10^3 copies/mL)]; 10. Any other disease, clinically significant metabolic, physical, or lab abnormalities, which in the investigator's opinion indicate the patient is unsuitable for the study drug (e.g., epilepsy requiring treatment), may affect study result interpretation, or place the patient at high risk; 11. Patients deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete response;Safety Endpoint;Progrssion Free Survival;Disease Control Rate;Overall survival;Major Pathological Response Rate; | — |
Countries
China
Contacts
Public ContactTing Deng
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed