Pancreatic cancer
Conditions
Interventions
Experimental Group:Nimotuzumab in Combination with Camrelizumab, Irinotecan Liposome (II), and Raltitrexed Therapy
Sponsors
Chongqing Medical University First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years; either sex. 2. Pathologically and/or cytologically confirmed diagnosis of pancreatic adenocarcinoma. 3. Locally advanced or metastatic pancreatic cancer confirmed by imaging (CT/MRI) that is not amenable to curative-intent surgery (per NCCN criteria). 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5. No prior systemic therapy for pancreatic cancer (including chemotherapy, targeted therapy, immunotherapy, or biologic therapy). If prior neoadjuvant or adjuvant therapy was received, the last dose must have been administered >6 months prior to documented recurrence/progression, and all treatment-related toxicities must have resolved to Grade =9.0 g/dL; absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count >=100×10^9/L. Total bilirubin (TBIL) 60 mL/min using the 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]). Coagulation function: International normalized ratio (INR) <=1.5 and activated partial thromboplastin time (APTT) <=1.5×ULN. 8. Life expectancy of at least 3 months. 9. Females of childbearing potential must agree to use medically acceptable methods of contraception throughout the study. 10. Able to comply with study procedures and voluntarily provide written informed consent prior to any study-specific screening procedures.
Exclusion criteria
Exclusion criteria: 1. Concurrent other primary malignancies (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). 2. Presence of severe comorbidities, including but not limited to: poorly controlled congestive heart failure (NYHA Class III or IV), unstable angina pectoris, poorly controlled arrhythmia, uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); active infection; poorly controlled diabetes (fasting plasma glucose persistently >9.0 mmol/L, or glycated hemoglobin [HbA1c] >7.5% despite antidiabetic treatment); uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension (e.g., history of esophageal and gastric variceal bleeding) or radiographic evidence of cavernous transformation of the portal vein; gastrointestinal obstruction (including gastric outlet obstruction or duodenal obstruction requiring decompression or stenting); respiratory insufficiency (requiring oxygen at rest or arterial partial pressure of oxygen [PaO2] <60 mmHg). 3. Major surgery within 4 weeks prior to the first dose of study drug (except diagnostic needle biopsy), or presence of unhealed, infected, or dehiscent surgical wounds. 4. Participation in any other clinical trial or receipt of any approved antineoplastic agent within 4 weeks prior to screening. 5. History of hypersensitivity to any study drug or to components of similar structure. 6. Presence of biliary obstruction without appropriate intervention. 7. Known HIV infection; untreated syphilis infection; active hepatitis (hepatitis B or C). Hepatitis B virus carriers (HBsAg positive) are excluded unless HBV DNA is <1000 copies/mL, and they have received at least 2 weeks of antiviral therapy prior to screening and are willing to continue treatment until study completion. 8. Pregnant or lactating women. 9. History of severe gastrointestinal disease, such as gastrointestinal bleeding within the past year (e.g., gastric ulcer bleeding, esophageal variceal rupture), active ulcerative colitis, or active Crohn’s disease (irinotecan liposome may induce diarrhea; underlying conditions that could exacerbate toxicity must be excluded). 10. Any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation (e.g., severe malnutrition, psychiatric illness preventing compliance with follow-up, or planned other antineoplastic therapy during the study period). 11. Prior treatment with any immunotherapeutic agents, including PD-1, PD-L1, or CTLA-4 inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free surviva;Time to Progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactYong Chen
Chongqing Medical University First Affiliated Hospital
Outcome results
None listed