Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer

NCT07277452 | Not Yet Recruiting Phase 2

• 1 other identifier: IST-Nim-PC-3
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. Led by The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \& Institute (as leading centers), its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer.

Conditions

Pancreatic Cancer, Adult

Keywords

Nimotuzumab; resectable pancreatic cancer; borderline resectable pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• overall survival (OS)

  Up to 24 months

• R0 resection rate

  within 30 days after surgery

• Surgical Resection rate

  within 30 days after surgery

• Objective response rate (ORR)

  Up to 9 weeks during the neoadjuvant treatment

• adverse events

  Up to 30 days after last administration

Study Arms (2)

Nimotuzumab+ AG

EXPERIMENTAL

Drug: Nimotuzumab; Drug: AG regimen

Placebo+ AG

PLACEBO COMPARATOR

Drug: AG regimen; Drug: Placebo

Interventions

Nimotuzumab DRUG

Patients will receive 3 cycles of neoadjuvant treatment with Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).

Nimotuzumab+ AG

AG regimen DRUG

Patients will receive 3 cycles of AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle).

Nimotuzumab+ AG; Placebo+ AG

Placebo DRUG

Patients will receive 3 cycles of neoadjuvant treatment with placebo (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant therapy (placebo 400 mg on days 1, 8, and 15 of a 21-day cycle).

Placebo+ AG

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);
• \. Confirmed as resectable/borderline resectable pancreatic cancer by CT/MRI imaging (resectability assessment refers to NCCN guidelines). For resectable pancreatic cancer, at least one of the following high-risk factors must be met: 1) CA199 \> 500 U/ml; 2) the maximum diameter of the primary tumor \> 3.0 cm; 3) Severe weight loss (BMI \< 18.5 kg/m² OR involuntary weight loss \> 15% within 6 months); 4) Severe pain (Numeric Rating Scale \[NRS\]≥ 4); 5) Definite regional lymph node metastasis (N1 or N2) OR suspicious regional lymph node metastasis (short-axis diameter of lymph nodes ≥15 mm);
• \. Voluntarily agree to sample collection (for KRAS gene testing and post-hoc analysis);
• \. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^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 (PS) 0-2;
• \. Life expectancy of at least 3 months;
• \. Women of childbearing age should have a negative result of serum HCG or urine pregnancy tests within 72 hours prior to randomization (Postmenopausal women who have had amenorrhea for at least 12 months are considered sterile and women known to have had tubal ligation are not required to undergo pregnancy tests) ;
• \. Good compliance and signed informed consent.

You may not qualify if:

• \. Previous treatment for pancreatic cancer.
• \. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); compensatory heart failure (NYHA grade III and IV), unstable angina or poorly controlled arrhythmias within 3 months prior to randomization; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; digestive tract obstruction; respiratory insufficiency and severe lung disease; central nervous system disease or mental illness;
• \. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal/other distant metastases;
• History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• \. Presence of bleeding or coagulation disorders;
• \. Known allergy to prescription or any component of the prescription used in this study;
• \. Known HIV infection, syphilis infection, or active hepatitis (hepatitis B or C);
• \. Women who are pregnant or are breastfeeding;
• Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (2)

Kuirong Jiang

Nanjing, Jiangsu, 210029, China

Location

Chunyi Hao

Beijing, 100000, China

Location

MeSH Terms

Conditions

Pancreatic cancer, adult

Interventions

nimotuzumab

Study Officials

• Kuirong Jiang, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Chunyi Hao

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuirong Jiang, MD

CONTACT

+8615312995688; jiangkuirong@njmu.edu.cn

Chunyi Hao, MD

CONTACT

13911501185; haochunyi@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 10, 2028
• Study Completion (Estimated): December 10, 2029
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

CN (2)