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Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer

Drug: Nimotuzumab Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg, 600mg, 400mg on Day 1, 8, 15, respectively, 28 days as a cycle, up to 6 cycles.

Other Names: h-R3

Drug: NALIRIFOX Patients will receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle, up to 6 cycles.

Other Names: NALIRIFOX

Nimotuzumab+ NALIRIFOX

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).

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.

Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer

A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer

The time from the beginning of treatment to death due to any cause.

The proportion of patients who underwent surgery.

PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.

To explore the influence of tumor-related markers such as CA199 and EGFR on prognosis.

Frequency and severity of adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer	NCT06429904	Locally Advance...	Nimotuzumab+ NA...	18 Years - 75 Years	Peking Union Medical College Hospital
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer	NCT06429904	Locally Advance...	Nimotuzumab+ NA...	18 Years - 75 Years	Peking Union Medical College Hospital
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer	NCT06429904	Locally Advance...	Nimotuzumab+ NA...	18 Years - 75 Years	Peking Union Medical College Hospital
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer	NCT06429904	Locally Advance...	Nimotuzumab+ NA...	18 Years - 75 Years	Peking Union Medical College Hospital

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