Nimotuzumab combined with AG for pancreatic cancer with liver metastasis

A Prospective, Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis

This study is testing if a new combination of Nimotuzumab and standard chemotherapy can help people with pancreatic cancer that has spread to the liver get better and possibly have surgery to remove the cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: nimotuzumab, chemotherapy
• Locations: 1 site (Tianjin)
• Trial ID: NCT06405685 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of Nimotuzumab in combination with AG (gemcitabine and nab-paclitaxel) for patients with pancreatic cancer that has spread to the liver. It is a prospective, open-label, single-arm study where patients will receive the treatment as conversion therapy, with imaging assessments conducted every two months. The primary goal is to determine the R0 resection rate, while secondary endpoints include overall survival, objective response rate, and safety evaluations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed pancreatic cancer and liver metastasis deemed potentially resectable.

Not a fit: Patients with prior systemic therapy for their tumor or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical resectability and overall survival for patients with advanced pancreatic cancer.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in improving outcomes for patients with advanced pancreatic cancer.

Eligibility criteria

Inclusion Criteria:

* 1. Age 18-75 years old, gender unlimited;
* 2. Histologically or cytologically confirmed pancreatic cancer with liver metastasis;
* 3. Pancreatic cancer with liver metastasis, which is considered to be potentially resectable judged by a multidisciplinary team;
* 4. Receive nimotuzumab-based conversion therapy for voluntary;
* 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)≤3×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 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. Life expectancy is 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. 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. Use of EGFR-mab or EGFR-TKI within 30 days;
* 7. Known allergy to prescription or any component of the prescription used in this study;
* 8. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
* 9. Grade 2 or above toxicity from prior treatment that has not resolved (excluding anemia, alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity)
* 10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Huikai Li, Dr

Conditions Pancreatic Cancer