Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study

Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases (PCLM): A Prospective, Single-Arm, Phase II Study

Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: nimotuzumab; Drug: AG chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300308
      • Recruiting
      • Tianjin Cancer Hospital Airport Hospital
      • Contact: Huikai Li, Doctor; Phone Number: 18622228639; Email: tjchlhk@126.com
      • Contact: Yang Liu, MD; Phone Number: 17694950696; Email: tjchlhk@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) Age: 18-75 years old; 2) Physical strength KPS ≥ 60 points; 3) Pancreatic ductal epithelial adenocarcinoma with liver metastasis that has been diagnosed by pathological histology or cytology and is not suitable for radical radiotherapy or surgical treatment (should be at least 6 months away from the last adjuvant chemotherapy); 4) According to the RECIST 1.1 evaluation criteria, there should be at least one measurable and evaluable objective lesion (the longest diameter of the target lesion on spiral CT examination should be ≥ 10mm; if there is only lymph node metastasis, the shortest diameter should be ≥ 15mm); 5) Expected survival time ≥ 3 months; 6) Serum AST/ALT ≤ 5 times ULN; Total bilirubin ≤ 3 times ULN; Absolute count of granulocytes ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Creatinine clearance rate ≥ 60ml/min; 7) Voluntarily participate in this study, sign an informed consent form, and have good compliance; 8) Patients of childbearing age and their spouses are willing to take contraceptive measures.

Exclusion Criteria:

• 1) Prior to this study, the following treatments were received:

  1. Antitumor chemotherapy and molecular targeted therapy as a palliative measure
  2. The target lesion has undergone radiotherapy without any progression
  3. Within 4 weeks or currently participating in other therapeutic/intervention clinical trials 2) Received major surgery within 4 weeks; 3) Existing brain metastasis or leptomeningeal metastasis; 4) Have a history of other malignancies other than pancreatic cancer (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for 5 years); 5) Merge symptomatic abdominal fluid that requires clinical treatment; 6) Accompanied by other serious illnesses, including but not limited to:
  1. Uncontrollable congestive heart failure (NYHA grade III or IV, see Appendix III), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to high blood pressure (SBP>160mmHg or DBP>100mmHg)
  2. Active infection
  3. Difficult to control diabetes
  4. Mental illnesses that affect informed consent and/or adherence to protocols
  5. HIV infection
  6. There are serious illnesses that other researchers believe are not suitable for participating in this study 7) Known to be allergic to anti EGFR antibody preparations. 1.3 Exclusion criteria
• Failure to conduct effectiveness and/or safety evaluations; Serious violation of the protocol: While participating in this study, other chemotherapy drugs and/or modern Chinese medicine preparations with anti-cancer indications were used for treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AG+nimotuzumab; Pts with potentially resectable, treatment-naïve PCLM received nimotuzumab (400 mg, iv, d1, qw) and AG chemotherapy (gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle).	Drug: nimotuzumab; nimotuzumab (400 mg, iv, d1, qw); Drug: AG chemotherapy; (gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	Primary endpoints were adverse events (AEs),	3month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical conversion rates	surgical conversion rates	3month
R0 resection rates	R0 resection rates	3month
pathological complete response (pCR) rate	pathological complete response (pCR) rate	3month

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: AG plus Nimotuzumab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No