pancreatic cancer
Conditions
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed pancreatic cancer (predominantly pancreatic ductal adenocarcinoma) by needle biopsy or surgical specimen; 2. Patients with initially diagnosed unresectable advanced pancreatic cancer, or those who have previously undergone radical resection of pancreatic cancer and are now confirmed to have postoperative recurrent pancreatic cancer; 3. Presence of pancreatic cancer–related pain, and assessed by the investigator as suitable for treatment with gabapentin or pregabalin; 4. Aged 18~70 years old; 5. Expected survival time >= 12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Adequate organ function and should meet the following standards: (1) Blood routine (no blood transfusion within 14 days): WBC >= 3.0 × 10^9/L; ANC >= 1.5 × 10^9/L; PLT >= 100 × 10^9/L; HGB >= 90 g/L; (2) Liver function: AST = 60 mL/min; (4) Coagulation function: INR <= 1.5, APTT <= 1.5 × ULN; (5) Adequate cardiac function assessed by electrocardiogram and color Doppler echocardiography. No myocardial infarction within the previous six months, and hypertension or other coronary heart diseases are currently under control; 8. There are no other uncontrollable benign diseases such as lung, kidney, or liver infections before enrollment; 9. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient has biliary obstruction or gastrointestinal obstruction suggested by imaging and clinical evaluation, with clinical signs of jaundice; 2. The patient has severe weight loss (e.g., >10% body weight loss within 6 months or >5% within 1 month, accompanied by very poor appetite), or cancer cachexia with a PG-SGA score of grade C; 3. The patient has severe hypoproteinemia (e.g., ALB 10 mg/day), or has used immunosuppressive drugs within 14 days before the first administration (Patients without active autoimmune disease, those using inhaled or topical glucocorticoids, and those using prednisone (> 10 mg/day) for hormone replacement therapy for adrenal insufficiency may be included); (3) The patient has received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month before the first administration; (4) The patient is participating in another clinical trial; (5) The patient has other malignant tumors requiring treatment (However, patients with basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the breast, or carcinoma in situ of the cervix who have received radical treatment and do not require other treatment may be enrolled); (6) The patient previously had severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 480 ms); grade III to IV cardiac insufficiency; left ventricular ejection fraction (LVEF) < 50% detected by color Doppler echocardiography; (7) The patient has a known history of organ transplantation or hematopoietic stem cell transplantation; (8) The patient received live vaccines within 30 days before the first administration; (9) The patient has other uncontrollable severe diseases (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction lower than 50%, renal insufficiency, urinary protein test 2+ or more); 6. Severe allergies and adverse drug reactions should be excluded: the patient is allergic or hypersensitive to any other drugs in the treatment regimen; 7. The patient suffering from mental illness, alcohol abuse, or drug abuse should be excluded; 8. Pregnant or lactating women; 9. The researcher believes that the patient is not suitable for inclusion, may affect the research results, or is not in the interest of the subject, or has abnormal laboratory indicators, should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Median progression-free survival;Objective response rate;Disease control rate;Duration of response;Median overall survival;Pain relief;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJiao Zuoyi
Lanzhou University Second Hospital
Outcome results
None listed