Unresectable Locally Advanced/Oligometastatic Pancreatic Cancer
Conditions
Interventions
Treatment Group:Combined treatment of I125 radioactive particle implantation with nimotuzumab and chemotherapy
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old; no gender restriction; 2. Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; 3. Confirmed by imaging as locally advanced or oligometastatic pancreatic cancer (with the number of metastatic organs = 2 and total number of metastases = 5), and ineligible for radical surgery (NCCN criteria); 4. ECOG Performance Status (PS) score of 0-1; 5. No prior treatment of any form for locally advanced/metastatic pancreatic cancer (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.); if previously received neoadjuvant or adjuvant therapy, ensure that the time interval from the last dose to recurrence/progression exceeds 6 months, and all toxicities related to prior treatment have resolved (= Grade 1 according to CTC AE 5.0 criteria, excluding toxicities such as alopecia that are judged by the investigator to pose no safety risk); 6. Presence of measurable lesions according to RECIST version 1.1 evaluation criteria; 7. Sufficient organ and bone marrow function: no blood transfusion or hematopoietic growth factor treatment within 14 days prior to screening, and meeting the following laboratory criteria: hemoglobin >= 90 g/L; neutrophil count >= 1.5 × 10^9/L; platelet count >= 90 × 10^9/L; total bilirubin (TBIL) 60 mL/min (using Cockcroft-Gault formula): for females, CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dL); for males, CrCl = (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dL); 8. ECOG PS score of 0-1 (repeated for emphasis, if necessary in the context); 9. Expected life expectancy of at least 3 months; 10. Patients of childbearing potential and their spouses are willing to take contraceptive measures; pregnancy test (serum or urine) to be performed within 3 days prior to the initiation of the first treatment for females of childbearing potential; females of childbearing potential should use highly effective contraceptive measures during treatment and for 6 months after the end of treatment; 11. Willing to sign an informed consent form voluntarily, with good compliance, and able to cooperate with the completion of treatment, follow-up, and various assessments.
Exclusion criteria
Exclusion criteria: 1. Refusal to undergo I125 radioactive particle implantation or treatment with nimotuzumab and chemotherapy; 2. Presence of other primary malignant tumors besides pancreatic cancer (excluding cured cutaneous basal cell carcinoma and cervical carcinoma in situ); 3. Known brain metastases or symptoms suggestive of brain metastases; 4. Concomitant severe underlying medical conditions, including but not limited to: a. Uncontrolled congestive heart failure (NYHA Class III or IV), unstable angina, poorly controlled arrhythmias (e.g., atrial fibrillation with rapid ventricular rate), or uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg); b. Active infection; c. Poorly controlled diabetes (persistent fasting blood glucose > 9.0 mmol/L or glycated hemoglobin > 7.5%, despite antidiabetic treatment); d. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage; e. Severe portal hypertension (e.g., esophageal or gastric varices with a history of bleeding) or imaging evidence of portal vein cavernous transformation; f. Gastrointestinal obstruction (including gastric outlet obstruction, duodenal obstruction requiring gastrointestinal decompression or stent placement); g. Respiratory insufficiency (requiring oxygen supplementation at rest or arterial oxygen partial pressure 1.5 × ULN, activated partial thromboplastin time > 1.5 × ULN, or ongoing anticoagulant therapy that cannot be temporarily discontinued); 7. Previous receipt of any form of first-line antitumor therapy for pancreatic cancer; 8. Known hypersensitivity to any of the drugs or their components used in this protocol; 9. Known HIV or syphilis infection, or active hepatitis (hepatitis B or C) (active hepatitis B is defined as HBsAg-positive with HBV DNA > 10^4 copies/mL or 2000 IU/mL; active hepatitis C is defined as HCV-Ab-positive with HCV RNA > 1000 copies/mL); 10. Pregnant or lactating women; 11. Other conditions deemed unsuitable for enrollment by the investigator (e.g., psychiatric disorders, history of drug abuse, inability to comply with follow-up, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;disease control rate;CA199 response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactHongxin Niu
Qilu Hospital of Shandong University (Qingdao)
Outcome results
None listed