pancreatic cancer
Conditions
Interventions
Test group:IBI389 + albumin-bound paclitaxel + Gemcitabine
Sponsors
First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Sign the written informed consent form and be able to comply with the visits and related procedures specified in the plan. b. Age =18 years and =75 years old. c. Unresectable, locally advanced recurrent or metastatic pancreatic ductal adenocarcinoma confirmed by histopathological examination. d. For patients who have previously received (neo)adjuvant chemotherapy/adjuvant (radio)chemotherapy/radical chemoradiotherapy, the time from the last treatment to disease recurrence is >6 months. e. Have not received any systemic treatment (including chemotherapy, targeted therapy, tumor immunotherapy, etc.) for locally advanced or metastatic disease. f. No history of allergy to albumin-paclitaxel and gemcitabine. g. Expected survival time =12 weeks. h. A score of 0 or 1 according to the Eastern Cooperative Oncology Group performance status (ECOG PS). i. The tumor pathological tissue test is confirmed to be CLDN18.2 positive, which is defined as the sum of the proportion of tumor cells with CLDN18.2 membrane staining intensity of 2+ and 3+ in the tumor tissue detected by immunohistochemistry =1% (before enrollment) Previous test results within 2 years or research center test results). j. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTV1.1), there is at least 1 measurable lesion (no previous radiotherapy). Accurate measurement by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline shows that its long diameter is =10 mm (except lymph nodes, the short axis of lymph nodes must be =15 mm), and the target lesion diameter is = The imaging layer is 2 times thicker and the lesions are suitable for repeated and accurate measurement. Lesions located in previously irradiated areas are considered measurable if they clearly demonstrate progression consistent with RECIST V1.1 criteria. k. Have adequate organ and bone marrow function, as defined below: l. Blood routine: neutrophil count =1.5×109/L; white blood cell count =20.0×109/L; platelet count =90×109/L; hemoglobin content =9.0 g/dL; lymphocyte count =0.5×109 /L. Note: Subjects must not have received treatment with blood products (such as red blood cell suspension, apheresis platelets, cryoprecipitate, etc.), erythropoietin or colony-stimulating factors within 7 days before collecting blood samples. m. Liver function: Serum total bilirubin (TBIL) = 1.5 × upper limit of normal value (ULN). Patients with confirmed Gilbert syndrome require TBIL = 3 × ULN. Patients without liver metastasis are required to have ALT and AST = 2.5×ULN, and patients with liver metastasis are required to have ALT and AST = 5×ULN; albumin = 28 g/L. n. Renal function: serum creatinine =1.5×ULN or creatinine clearance =50ml/min (creatinine clearance calculated using Cockcroft-Gault formula or standard 24-hour urine retention method); urine protein <2+ or 24-hour urine protein quantification <1 g. o. Coagulation function: activated partial thromboplastin time =1.5×ULN and international normalized ratio =1.5. p. Female subjects of childbearing age or male subjects whose partners are women of childbearing age must take effective contraceptive measures during the entire treatment period and within 180 days after the treatment period.
Exclusion criteria
Exclusion criteria: 1. Are participating in another interventional clinical study, except for observational (non-interventional) clinical studies or in the survival follow-up phase of an interventional study. 2. Have received other antitumor therapy, including systemic chemotherapy, targeted therapy, immunotherapy, intraperitoneal perfusion chemotherapy, tumor embolization or interventional chemotherapy, etc. within 4 weeks before the first administration of the study drug. For oral chemotherapy drugs, small molecule targeted drugs, endocrine therapy and Chinese herbal medicines for anti-tumor purposes, the elution period is 2 weeks or 5 half-lives, whichever is longer. 3. Use of immunosuppressive drugs within 4 weeks prior to the first administration of the study drug, excluding d. Intranasal inhaled topical steroid therapy or topical steroid injections (eg, intra-articular injections). e. Systemic corticosteroid therapy with prednisone not exceeding 10 mg/day or its equivalent physiologic dose. f. Corticosteroids as a prophylaxis for anaphylaxis (eg, before CT). 4. Requires long-term systemic hormone or any other immunosuppressive drug treatment, excluding inhaled sex hormone therapy. 5. Receive live attenuated vaccine within 4 weeks prior to the first dose of the study drug or planned for the duration of the study. 6. The presence of toxicities (excluding alopecia, fatigue, or grade 2 peripheral sensory neuropathy) due to prior anti-tumor therapy that do not resolve to NCI CTCAE v5.0 grade 0 or 1 in the 4 weeks prior to the first dose of study drug. 7. Have undergone major surgery (craniotomy, thoracotomy or laparotomy or other defined by the investigator) or have unhealed wounds, ulcers or fractures within 4 weeks before the first administration of the study drug; Note: For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable. 8. Have received total pelvic radiotherapy in the past. 9. Expected to receive other anti-tumor treatments during trial treatment (palliative radiotherapy is allowed). 10. There is recurrent vomiting within 2 weeks before the first dose of study treatment (such as vomiting = 2 times within 24 hours, or medical intervention such as rehydration is required). 11. Known central nervous system (CNS) metastasis and/or spinal cord compression and/or cancerous meningitis, and a history of leptomeningeal carcinoma. Patients with asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroid treatment, and brain metastases =1.5 cm) or patients with stable symptoms after treatment of brain metastases who meet all the following criteria can participate in this project Study: No midbrain, pontine, cerebellar, meningeal, bulbar, or spinal cord metastases; clinically stable for at least 4 weeks with conclusive clinical evidence of no new or expanding brain metastases, and discontinued corticosteroids and anticonvulsants prior to study treatment Drug treatment is required for at least 14 days; however, the brain needs to be regularly examined as the site of the disease; Note: The central nervous system is not considered a measurable lesion. 12. Patients with bone metastases who are at risk of spinal cord compression and paraplegia, or bone metastases who are at risk of fractures in load-bearing bones such as the pelvis and lower limbs; 13. Pneumonia or interstitial lung diseases that require treatment in the past and currently: such as pulmonary fibrosis, pneumoconios
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Adverse Event;Serious Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Time to Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactDu Yingying
First Affiliated Hospital of Anhui Medical University
Outcome results
None listed