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Not yet recruitingNCT06781086NOTABLE-309Updated Jan 17, 2025

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

A Phase 2 interventional study of Nimotuzumab and AG regimen in Pancreatic Cancer, Adult, sponsored by Biotech Pharmaceutical Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Biotech Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study 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.

Read the detailed description

This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study 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. About 156 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus AG) and control group (placebo plus AG) at a ratio of 1:1. The main endpoint is disease-free survival (DFS). Additional end points include overall survival (OS), R0 resection rate, preoperative objective response rate (ORR), postoperative complications and safety, etc.

02

Conditions studied

  • Pancreatic Cancer, Adult

Keywords

  • Nimotuzumab
  • resectable pancreatic cancer
  • borderline resectable pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's planned enrollment of 156 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Biotech Pharmaceutical Co., Ltd. is the lead sponsor of 31 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age 18-75 years old, gender unlimited;
    1. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
    1. Confirmed as resectable/borderline resectable pancreatic cancer by CT/MRI imaging (resectability assessment refers to the NCCN criteria). If it is resectable pancreatic cancer, any of the following high-risk factors should also be met: 1) Carbohydrate Antigen 19-9(CA199) > 500 U/ml; 2) the maximum diameter of the primary tumor > 3.0 cm; 3) severe weight loss; 4) Extreme pain; regional lymph node metastasis (N1 or N2);
    1. Voluntarily accept sample collection (for KRAS gene testing and subsequent analysis);
    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≥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;
    1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
    1. Life expectancy of at least 3 months;
    1. Women of childbearing age should have a negative result of serum human chorionic gonadotropin (HCG) test or urine pregnancy test 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);
    1. Good compliance and signed informed consent.

Exclusion criteria

Exclusion Criteria:

    1. Previous treatment for pancreatic cancer.
    1. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (Systolic Blood Pressure>160mmHg or Diastolic Blood Pressure>100mmHg); compensatory heart failure (New York Heart Association (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;
    1. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal/other distant metastases;
  • 4.History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
    1. bleeding or clotting disorder;
    1. Known allergy to prescription or any component of the prescription used in this study;
    1. With human immunodeficiency virus (HIV) or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
    1. Women who are pregnant or are breastfeeding;
  • 9.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    Nimotuzumab+ AG

    Drug: Nimotuzumab · Drug: AG regimen

  • Placebo comparator
    Placebo+ AG

    Drug: AG regimen · Drug: Placebo

Interventions

  • DrugNimotuzumab

    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).

  • DrugAG regimen

    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).

  • DrugPlacebo

    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).

06

What researchers measure

Primary outcomes

  1. disease-free survival (DFS)

    The time from the date of surgery to the disease recurrence or death, whichever is earlier.

    Time frame: Up to 24 months

Secondary outcomes

  1. overall survival (OS)

    The time from the date of randomization to death due to any cause.

    Time frame: Up to 24 months

  2. R0 resection rate

    Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

    Time frame: within 30 days after surgery

  3. Surgical Resection rate

    Patients who undergo surgical resection will be documented.

    Time frame: within 30 days after surgery

  4. 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.

    Time frame: Up to 9 weeks during the neoadjuvant treatment]

  5. adverse events

    Frequency and severity of adverse events.

    Time frame: Up to 30 days after last administration

07

Study locations

2 sites
  • Beijing Cancer Hospital
    Beijing, Beijing 100000, China
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 210029, China
    • Kuirong Jiang, Dr · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06781086
Lead sponsor
Biotech Pharmaceutical Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute, The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
Jan 20, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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