Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer

Locally Advanced Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06429904
• Other study ID #: IST-Nim-PC-29
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 15, 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Nimotuzumab+ NALIRIFOX
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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)	The time from the beginning of treatment to death due to any cause.	Up to 24 months
Secondary	resection rate	The proportion of patients who underwent surgery.	Up to 24 months
Secondary	progression-free survival (PFS)	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.	Up to 24 months
Secondary	Objective response rate (ORR)	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.	Up to 12 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