Clinical trial NCT06429904: Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer
Official title: A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Keywords: Nimotuzumab
locally advanced pancreatic cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).

Detailed description: This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC). Patients will receive Nimotuzumab plus NALIRIFOX as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is overall survival (OS). Additional end points included resection rates, progression-free survival (PFS), objective response rate (ORR), safety, etc.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years old, gender unlimited;
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
3. Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging;
4. Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation;
5. No prior tumor systemic therapy.
6. Measurable disease according to RECIST criteria v1.1;
7. 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;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Postoperative survival was expected to be ≥3 months;
10. Fertile subjects are willing to take contraceptive measures during the study period.
11. Good compliance and signed informed consent voluntarily.

Exclusion Criteria:

1. Refuse chemotherapy or surgery;
2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
3. 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;
4. Undergone major surgery within 30 days;
5. Use of EGFR-mab or EGFR-TKI within 30 days;
6. Known allergy to prescription or any component of the prescription used in this study;
7. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
8. Other reasons that are not suitable to participate in this study according to the researcher's judgment

Primary outcomes:
measure: overall survival (OS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: resection rate
timeFrame: Up to 24 months
measure: progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Objective response rate (ORR)
timeFrame: Up to 12 months
measure: tumor-related markers
timeFrame: Up to 24 months
measure: adverse events
timeFrame: Up to 30 days after last administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: