Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer

NCT06722911 | Recruiting Phase 2

• 1 other identifier: IST-Nim-PC-42
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.

Conditions

Pancreatic Cancer Resectable

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 (4)

• distant metastasis-free survival (DMFS)

  Up to 24 months

• overall survival (OS)

  Up to 24 months

• tumor-related markers

  Up to 24 months

• adverse events

  Up to 30 days after last administration

Study Arms (1)

Nimotuzumab+ AG

EXPERIMENTAL

Drug: Nimotuzumab; Drug: AG

Interventions

Nimotuzumab DRUG

Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.

Nimotuzumab+ AG

AG DRUG

Patients will receive nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1,000 mg/m\^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.

Nimotuzumab+ 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:

• \. Able and willing to provide a written informed consent.
• \. Age 18-75 years old, gender unlimited;
• \. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
• \. Postoperative pathology suggested R0/R1 resection;
• \. EGFR positive (by immunohistochemistry);
• \. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
• \. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^9/L; hemoglobin≥9.0 g/dL; 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 is expected to be ≥3 months;
• \. Fertile subjects are willing to take contraceptive measures during the study period.

You may not qualify if:

• \. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
• \. 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;
• \. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
• \. CA199\>180 U/ml within 21d before adjuvant therapy;
• \. Known allergy to prescription or any component of the prescription used in this study;
• \. Known HIV, 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

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

nimotuzumab

Study Officials

• Yiping Mou, Dr

  Zhejiang Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Yiping Mou, Dr

CONTACT

0086-057185893643; mouyiping@hmc.edu.cn

Tao Xia, Dr

CONTACT

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: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)