Clinical trial NCT06405685: Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis
Official title: A Prospective, Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 30
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 AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG 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 main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

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 AG (gemcitabine and nab-paclitaxel) in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG 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 and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

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.

Primary outcomes:
measure: R0 resection rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: resection rate
timeFrame: Up to 18 months
measure: overall survival (OS)
timeFrame: Up to 18 months
measure: Objective response rate (ORR)
timeFrame: Up to 18 months
measure: tumor-related markers
timeFrame: Up to 18 months
measure: adverse events
timeFrame: Up to 30 days after last administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jihui Hao, Dr
role: STUDY_CHAIR
References: