Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer

NCT06429904 | Active Not Recruiting Phase 2

• 1 other identifier: IST-Nim-PC-29
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Nimotuzumab; locally advanced pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  The time from the beginning of treatment to death due to any cause.

  Up to 24 months

Secondary Outcomes (5)

• resection rate

  Up to 24 months

• progression-free survival (PFS)

  Up to 24 months

• Objective response rate (ORR)

  Up to 12 months

• tumor-related markers

  Up to 24 months

• adverse events

  Up to 30 days after last administration

Study Arms (1)

Nimotuzumab combined with NALIRIFOX

EXPERIMENTAL

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

Drug: Nimotuzumab+ NALIRIFOX

Interventions

Nimotuzumab+ NALIRIFOX 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

Nimotuzumab combined with NALIRIFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, gender unlimited;
• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
• Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging;
• Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation;
• No prior tumor systemic therapy.
• Measurable disease according to RECIST criteria v1.1;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Postoperative survival was expected to be ≥3 months;
• Fertile subjects are willing to take contraceptive measures during the study period.
• Good compliance and signed informed consent voluntarily.

You may not qualify if:

• Refuse chemotherapy or surgery;
• History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• 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;
• Undergone major surgery within 30 days;
• Use of EGFR-mab or EGFR-TKI within 30 days;
• Known allergy to prescription or any component of the prescription used in this study;
• With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
• Other reasons that are not suitable to participate in this study according to the researcher's judgment

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)