Patients with HER2-altered gastric and gastroesophageal junction adenocarcinoma
Conditions
Interventions
Treatment Group:Trastuzumab-Rezetecan 4.8 mg/kg intravenously every 3 weeks plus Apatinib 250 mg orally once daily, continued until disease progression or unacceptable toxicity.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study, signs the informed consent form, demonstrates good treatment compliance, and is willing to complete follow-up visits. 2. Aged >= 18 years, with no restriction on gender. 3. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). HER2 alterations verified by next-generation sequencing (NGS) or immunohistochemistry (IHC). HER2 alterations include the following three types: (1) HER2 mutation (NGS test results of tissue or blood samples from CLIA- or CAP-certified laboratories are acceptable); (2) Primary HER2 amplification (NGS or FISH test results of tissue or blood samples from CLIA- or CAP-certified laboratories are acceptable); (3) HER2 protein overexpression. 4. Has received at least one line of prior systemic therapy (including chemotherapy and immunotherapy), with documented disease progression or intolerance to previous treatment. 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0–2. 6. Estimated overall survival of no less than 3 months. 7. Adequate function of major organs (laboratory test results obtained within 7 days prior to enrollment shall meet the following criteria): (1) Hematological parameters (no blood transfusion, granulocyte colony-stimulating factor or hematopoietic corrective drugs administered within 14 days prior to screening): 1) Absolute neutrophil count (ANC) >= 1.5×10?/L; 2) Platelet count >= 75×10?/L; 3) Hemoglobin >= 90 g/L. (2) Biochemical parameters (no albumin infusion administered within 14 days prior to screening): 1) Serum creatinine 50 mL/min; 2) Total serum bilirubin <= 1.5 × ULN; c) Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 × ULN. (3)) Coagulation function: 1) International Normalized Ratio (INR) <= 2.3, or prothrombin time (PT) prolongation = 6 seconds compared with the normal control range. 8.Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days before enrollment, and agree to use effective contraception throughout the study period and for 8 weeks after the last study drug administration. Male subjects must be surgically sterilized or agree to use effective contraception throughout the study period and for 8 weeks after the last study drug administration. 9.Subjects who are considered suitable to derive clinical benefits from the study treatment by the investigator.
Exclusion criteria
Exclusion criteria: 1. The tumor has distant metastasis, or peritoneal metastasis is confirmed via laparoscopy; 2. Patients with other severe immunosuppressive diseases or concomitant malignant tumors. 3. Patients with severe recurrent uncontrolled infections, other severe uncontrolled concomitant diseases, severe psychiatric disorders, or severe respiratory diseases; severe hepatic or renal insufficiency; history of unstable angina pectoris or myocardial infarction within the past 6 months; history of cerebral infarction or cerebral hemorrhage within the past 6 months; continuous systemic glucocorticoid therapy within the past 1 month (topical use excluded). 4. Patients diagnosed with any other malignant tumor within the past 5 years. 5. Patients with known allergy to the active ingredients or excipients of the investigational product. 6. Pregnant or breastfeeding women. 7. Patients with a history of psychotropic drug abuse, alcoholism or drug addiction. 8. Patients with concomitant diseases that may endanger patient safety or interfere with study completion as judged by the investigator (including but not limited to drug-refractory severe hypertension, severe pulmonary dysfunction, uncontrolled severe diabetes), or any other conditions deemed ineligible for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Duration of Response;Disease Control Rate;Objective Response Rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactJiqing Hao
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed