Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer

NCT ID: NCT06429904

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2027-05-31

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 NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).

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 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.

Conditions

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab combined with NALIRIFOX

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

Group Type: EXPERIMENTAL

Nimotuzumab+ NALIRIFOX

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

IST-Nim-PC-29

Identifier Type: -

Identifier Source: org_study_id