Pancreatic ductal adenocarcinoma
Conditions
Interventions
TQB2916 combined with gemcitabine:venoclysis
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent; 2. The age is 18-75 years old (the time of signing the informed consent form, including the critical value); 3. Pancreatic ductal adenocarcinoma confirmed by tissue or cytology (excluding other mixed pancreatic cancers); 4. Having at least one measurable lesion according to the RECIST 1.1 standard; 5. Without any systematic anti-tumor treatment; 6.The score of ECOG is 0-1, and the estimated survival time is more than 3 months. 7.The main organs function well;7.1. Routine blood examination criteria (no blood transfusion within 7 days before the examination, no correction with hematopoietic stimulating factor drugs): a. Hemoglobin (HGB) >=100 g/L; b. Absolute neutrophil value (NEUT) >=1.5×10^9/L; c. Platelet count (PLT) >= 100×10^9/L; 7.2. Biochemical tests are subject to the following criteria: a. Total bilirubin (TBIL) =60 ml/min; 3) Coagulation function must meet the following criteria: international normalized ratio (INR) =50% 8.Patients must adopt reliable contraceptive measures during the study period and within 6 months after the end of the study period; The serum pregnancy test was negative within 7 days before the study was enrolled, and it must be a non-lactating subject.
Exclusion criteria
Exclusion criteria: 1.Concomitant diseases and medical history: 1) The subject had other malignant tumors in the past or at the same time within 5 years (except the cured basal cell carcinoma of skin and cervical carcinoma in situ); Suffering from other malignant tumors, but the following two situations can be included in the group: other malignant tumors treated by single operation have achieved R0 resection without recurrence and metastasis for 5 years; Cured cervical carcinoma in situ, basal cell carcinoma of skin, nasopharyngeal carcinoma and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 2) Unresolved toxic reaction caused by any previous treatment, which is higher than CTC AE level 1 or above, excluding alopecia; 3) He has received major surgical treatment, obvious traumatic injury or long-term unhealed wound or fracture within 28 days before taking the drug for the first time; 4) Patients with any bleeding or bleeding event >=CTC AE 3 within 4 weeks before the first administration; 5) Patients who have suffered from arteriovenous thrombosis within 6 months before the first administration, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism. 6) HBV infected people can't receive regular antiviral treatment in the whole process; HCV infection (HCV Ab or HCV RNA positive): The researchers judged that they were in an unstable state, or they needed to continue antiviral treatment and could not receive regular antiviral treatment during the research; 7) active syphilis; 8) Those who have a history of psychotropic drug abuse and can't quit or have mental disorders; 9) Symptomatic interstitial lung disease, and conditions that may cause drug-induced pulmonary toxicity or associated pneumonia; 10) Subjects with any serious and/or uncontrollable diseases;a. Poor blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); b. Grade >=2 myocardial ischemia or myocardial infarction and Grade >=2 congestive heart failure (New York Heart Association (NYHA) classification); c. Arrhythmia: including male QTc >=450ms (male), QTc >=470ms (female), frequent premature ventricular episodes, significant sinus brady, etc., which are considered by the investigator and relevant departments to have a high risk of malignant arrhythmia, or other conditions that may cause malignant arrhythmia as judged by the investigator; d. Presence of acute and chronic pancreatitis-related clinical or biochemical manifestations, or high-risk factors for the occurrence of pancreatitis (investigator assessment). Active or uncontrolled severe infection (>= CTC AE Grade 2 infection); f. Patients with renal failure requiring hemodialysis or peritoneal dialysis; g. Those with a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; h. Poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10mmol/L); i. Those whose urine routine shows a urine protein =++, and the 24-hour urine protein quantification > 1.0 g; j. Those who have epilepsy and need treatment; 2.(2) Tumor-related symptoms and treatment: 1) Patients whose imaging (CT or MRI) shows that the tumor has invaded the periphery of important blood vessels, and the researchers judge that the tumor is likely to invade important blood vessels and cause fatal hemorrha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Duration of Overall Response;Disease control rate;Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactBa Yi
Peking Union Medical College Hospital
Outcome results
None listed