HER2-Positive Advanced Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Group A:Trasturzrmab
Group B:Trasturzrmab and Camrelizumab
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent form; 2. Age >= 18 years; 3. Pathologically confirmed advanced esophageal squamous cell carcinoma (ESCC) with HER2 positivity (IHC 2+/3+ in cell membrane or cytoplasm, or positive DISH); 4. Progression after standard first-line immunotherapy combined with chemotherapy (confirmed by RECIST v1.1); 5. ECOG performance status score of 0-1; 6. Expected survival = 3 months; 7. At least one measurable lesion according to RECIST v1.1; 8. Vital organ function meets the following requirements within 1 week prior to enrollment (no blood products or hematopoietic growth factors are allowed within 14 days before enrollment): Absolute neutrophil count (ANC) >= 1.5×10?/L; 8.1 Platelet count >= 90×10?/L; 8.2 Hemoglobin >= 90 g/L; 8.3 Total bilirubin 60 mL/min (calculated by Cockcroft-Gault formula); 9. Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment, and agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of study drug,for men, they must be surgically sterilized or agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of study drug. 10.Have not participated in other clinical trials within 4 weeks prior to enrollment and during the treatment period.
Exclusion criteria
Exclusion criteria: 1. Unable to comply with the study protocol or procedures. 2. Prior treatment with anti-HER2 targeted therapy. 3. Experienced grade >=3 immune-related adverse events (CTCAE v5.0) during first-line immunotherapy. 4. Received live vaccine within 4 weeks prior to enrollment or likely to receive live vaccine during the study period. 5. Had other malignancies within 5 years prior to enrollment, except for curatively resected basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma, or cervical carcinoma in situ. 6. Has active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment. 7. Previously received allogeneic bone marrow transplantation or organ transplantation. 8. Developed severe cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction. 9. Subjects with known allergy to the study drug or any of its excipients. 10. International normalized ratio (INR) >1.5, or activated partial thromboplastin time (APTT) >1.5×ULN. 11. Electrolyte abnormalities judged to be clinically significant by the investigator. 12. Uncontrolled hypertension despite medication prior to enrollment, defined as systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg. 13. Evidence or history of obvious bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, accompanied by hematemesis, melena, or hematochezia), hemoptysis (>5 mL fresh blood within 4 weeks), or occurrence of thromboembolic events (including stroke and/or transient ischemic attack) within 12 months. 14. Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; cardiac function (NYHA) class >2 for congestive heart failure; ventricular arrhythmia requiring medication; left ventricular ejection fraction (LVEF) =CTCAE v5.0 grade 2 infection). 16. Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis [for known hepatitis B virus (HBV) carriers, active HBV infection must be excluded, i.e., HBV DNA-positive (>1×104 copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA-positive (>1×10³ copies/mL)]. 17. Any other disease, clinically significant metabolic abnormality, abnormal physical examination, or abnormal laboratory finding that, in the investigator’s judgment, reasonably suggests a condition or state (e.g., epilepsy requiring treatment) that would make the subject unsuitable for the use of the study drug, or that would affect the interpretation of study results, or place the subject at high risk. 18. Urinalysis shows urine protein =2+ and 24-hour urine protein >1.0 g. 19. Comorbidities requiring long-term use of immunosuppressants, or requiring systemic or topical immunosuppressive corticosteroids (>10 mg/day prednisone or other therapeutic hormones). 20. Subjects judged by the investigator to be unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Safety;Overall Survival;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactYongkun Sun
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed