Status:
NOT_YET_RECRUITING
AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Pancreatic Cancer, Adult
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of nab-paclitaxel/gemcitabine combined with nimotuzumab sequ...
Detailed Description
This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of nab-paclitaxel/gemcitabine combined with nimotuzumab sequential irreversi...
Eligibility Criteria
Inclusion
- 1\. Age 18-75 years old, gender unlimited;
- 2\. Histologically or cytologically confirmed pancreatic cancer;
- 3\. Confirmed as locally advanced pancreatic cancer by CT/MRI imaging, with no evidence of distant metastasis;
- 4\. No prior chemotherapy or other tumor systemic therapy;
- 5\. Measurable disease according to RECIST criteria v1.1;
- 6\. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
- 7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- 8\. Life expectancy is expected to be ≥3 months;
- 9\. Fertile subjects are willing to take contraceptive measures during the study period.
- 10\. Good compliance and signed informed consent voluntarily.
Exclusion
- 1\. Refuse chemotherapy or surgery;
- 2\. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
- 3\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 4\. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- 5\. Undergone major surgery within 30 days;
- 6\. Participated in other drug related clinical trials within 4 weeks;
- 7\. Known allergy to prescription or any component of the prescription used in this study;
- 8\. With HIV, or active hepatitis (hepatitis B, hepatitis C);
- 9\. Failure to recover from treatment-related toxicity to ≤ grade 1 (adverse events such as alopecia judged by the researcher not to affect the treatment with the research drug are excluded);
- Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06938503
Start Date
April 21 2025
End Date
April 28 2028
Last Update
April 22 2025
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