Pancreatic Cancer
Conditions
Interventions
Single-Arm Trial:HLX22 + Trastuzumab + Chemotherapy (Nab-Paclitaxel + Gemcitabine)
Sponsors
ZHONGSHAN HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be enrolled in this study: Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures. No gender restrictions; age >= 18 years and = 3 months. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), HBV-DNA must be < 2500 copies/mL or 500 IU/mL or within the normal range at the study center. HCV antibody (-); if HCV antibody (+), HCV-RNA must be negative for enrollment. Subjects with co-infection of hepatitis B and hepatitis C (positive HBsAg or HBcAb, and positive HCV antibody) are excluded. HIV antibody (-). Adequate organ function. Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment and for at least 7 months after the last dose.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will not be eligible for this study: Patients with other malignancies within 2 years prior to the first dose. Cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, and thyroid cancer may be enrolled. Prior cumulative doxorubicin exposure > 360 mg/m^2 (or equivalent). Note: Equivalent agents include epirubicin > 720 mg/m^2, mitoxantrone > 120 mg/m^2, idarubicin > 90 mg/m^2, liposomal doxorubicin exceeding 360 mg/m^2 doxorubicin equivalent, or other anthracyclines. If more than one anthracycline has been used, the cumulative dose must not exceed 360 mg/m^2 doxorubicin equivalent. Prior treatment with any HER2-targeted therapy. Active gastrointestinal bleeding (assessed as >= Grade 2 toxicity per NCI CTCAE v5.0). Presence of central nervous system (CNS) and/or leptomeningeal metastases. History of cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia (including QTc interval >= 450 ms for males or >= 470 ms for females) within 6 months prior to the first dose (QTc interval calculated using Fridericia’s formula). Grade III-IV cardiac dysfunction per New York Heart Association (NYHA) criteria, or left ventricular ejection fraction (LVEF) < 55% on echocardiography. History or current evidence of interstitial lung disease; active infection requiring systemic therapy or active tuberculosis. Treatment with live attenuated vaccines within 28 days prior to the first dose; except for inactivated vaccines for seasonal influenza or COVID-19. Major surgery within 28 days prior to the first dose of the study drug. Curative radiotherapy within 28 days prior to the first dose. Concurrent participation in other clinical studies, or use of other investigational drugs or medical devices within 28 days prior to the first dose in this study. Known history of severe allergy to any monoclonal antibody or excipients of the study drug. Known history of drug abuse or substance addiction. Pregnant or lactating women. Any other condition deemed by the investigator to potentially lead to premature termination of the study, including severe concomitant illnesses (including psychiatric disorders) requiring treatment, severe laboratory abnormalities, or familial/social factors that may compromise patient safety or data integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) (assessed by the investigator according to RECIST v1.1 criteria);Overall Survival (OS);Duration of Response (DOR) (assessed by the investigator according to RECIST v1.1 criteria);Disease Control Rate (DCR) (assessed by the investigator according to RECIST v1.1 criteria);Incidence of Adverse Events (AE) and Serious Adverse Events (SAE); | — |
Countries
China
Contacts
Public ContactLiang Liu
ZHONGSHAN HOSPITAL
Outcome results
None listed