Pancreatic cancer
Conditions
Interventions
Experimental group:Administer HLX43. The administration time is on the first day of each cycle. It is administered by intravenous infusion. A three-week period constitutes one administration cycle.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before the trial, one must fully understand the trial content, process, and possible adverse reactions, sign the informed consent form, voluntarily participate in the trial, and be able to complete the research as required by the trial protocol. 2. When signing the ICF, the age should be >= 18 years old and = 80×10^9/L, Hemoglobin (Hb) >= 90g/L, Lymphocytes (LYM) >= 0.8×10^9/L. Liver function: Total bilirubin (TBIL) <= 1.5×upper limit of normal (ULN), obstructive jaundice in the subject with total bilirubin <= 2×ULN; For Gilbert syndro
Exclusion criteria
Exclusion criteria: 1.Tumor histology or cytology confirmed as other pathological types of pancreatic cancer or combined with differentiation of other pathological types; 2.Previously received targeted topoisomerase I ADC drug; 3.Received radical radiotherapy within 3 months prior to the first drug administration; 4.History of any second malignancy within the past 2 years, except for early-stage malignancies treated with radical treatment (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, or papillary thyroid carcinoma; 5.Previous occurrence of adverse events leading to permanent discontinuation of immunotherapy, or previous occurrence of = Grade 2 immune-related pneumonia or immune-related myocarditis; 6.There is uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 7.Presence of spinal cord compression or clinically active central nervous system metastases (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control related symptoms), meningitis carcinomatosa, meningioma, or leptomeningeal disease. Subjects who have previously received treatment for brain metastases (such as whole-brain radiotherapy or brain stereotactic radiotherapy) may participate in the study, provided they have been clinically stable for at least 4 weeks with no imaging evidence of brain metastases progression. 8.Past and current clinical severe lung injury caused by pulmonary disease complications, including but not limited to any underlying pulmonary diseases (such as pulmonary embolism within 3 months prior to the first drug administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or subjects with a history of pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity; subjects with radiation pneumonitis within 6 months; 9.Subjects with poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure or left ventricular ejection fraction (LVEF) 150 mmHg and/or diastolic blood pressure >100 mmHg despite active treatment); 10.Active systemic infectious disease requiring intravenous antibiotic therapy within the previous two weeks; 11.Used strong inhibitors or inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization; 12.Patients who received systemic corticosteroids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressant therapy within 2 weeks prior to randomization; excluding the following situations: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; short-term use of corticosteroids for proph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of relief;Progression-free survival period;Overall survival period; | — |
Countries
China
Contacts
Public ContactYu xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed