Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Single-arm, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389760
• Other study ID #: IST-Nim-PC-16
• Status: Recruiting
• Phase: Phase 2
• Start date: October 18, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: August 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Juan Du, MD
• Phone: 86-25-83106666
• Email: dujuanglyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer.

Description:

This clinical study is designed as a prospective, multicenter, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), quality of life, tumor-related markers and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. Age 18-70 years old, gender unlimited;

• 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) with no evidence of distant metastasis as demonstrated by imaging;

• 3. Postoperative pathology suggested R0/R1 resection;

• 4. Receive nimotuzumab and mFOLFIRINOX for voluntary;

• 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 1;

• 8. Postoperative survival was 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 Criteria:

• 1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma;

• 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; 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. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;

• 5. CA199>180 U/ml within 21d before adjuvant therapy;

• 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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Nimotuzumab
Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles)
• mFOLFIRINOX
Patients will receive mFOLFIRINOX as follows: Oxaliplatin 68 mg/m2 on Day 1 and 15 of a 28-day cycle; Irinotecan 135 mg/m2 on Day 1 and 15 of a 28-day cycle; Leucovorin(LV) 400 mg/m2 Day 1 and 15 of a 28-day cycle; 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day 1 and 15 of a 28-day cycle (6 cycles).

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival (DFS)	The time from the date of surgery to the disease recurrence or death, whichever is earlier.	Up to 24 months
Secondary	distant metastasis-free survival (DMFS)	The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier.	Up to 24 months
Secondary	overall survival (OS)	The time from the date of surgery to death due to any cause.	Up to 24 months
Secondary	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)	Quality of Life will be evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). The scale assesses symptoms, functionality, and overall health status/ life quality. Each item is transformed to a 0-100 scale according to a standardized scoring procedure. Higher scores indicate more severe symptoms, while in the functionality and overall health status/life quality sections, higher scores signify better conditions.	Up to 24 months
Secondary	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ-PAN26)	Quality of Life will also be evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ- PAN26). EORTC-QLQ- PAN26 is a supplementary questionnaire module to be employed in conjunction with the Quality of Life Questionnaire Core 30 (QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.	Up to 24 months
Secondary	tumor-related markers	To explore the influence of tumor-related markers such as CA199 and EGFR on prognosis.	Up to 24 months
Secondary	adverse events	Frequency and severity of adverse events.	Up to 30 days after last administration