Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis

NCT06405685 | Unknown Phase 2

• 1 other identifier: IST-Nim-PC-5
• Study Type: interventional
• Target: 30
• 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 AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The Proportion of patients who achieved R0 resection (incisal edge\>1cm)

  Up to 6 months

Secondary Outcomes (5)

• resection rate

  Up to 18 months

• overall survival (OS)

  Up to 18 months

• Objective response rate (ORR)

  Up to 18 months

• tumor-related markers

  Up to 18 months

• adverse events

  Up to 30 days after last administration

Study Arms (1)

Nimotuzumab+AG

EXPERIMENTAL

Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy.

Drug: Nimotuzumab; Drug: AG

Interventions

Nimotuzumab DRUG

Nimotuzumab 400 mg will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery.

Also known as: h-R3

Nimotuzumab+AG

AG DRUG

Patients will receive AG as conversion therapy up to 6 months. Gemcitabine 1000 mg/m\^2 will be administered on Day 1, 8, 15 of a 28-day cycle. nab-Paclitaxel 125 mg/m\^2 will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery.

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:

• \. Age 18-75 years old, gender unlimited;
• \. Histologically or cytologically confirmed pancreatic cancer with liver metastasis;
• \. Pancreatic cancer with liver metastasis, which is considered to be potentially resectable judged by a multidisciplinary team;
• \. Receive nimotuzumab-based conversion therapy for voluntary;
• \. 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)≤3×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 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;
• \. Life expectancy is 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;
• \. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
• \. 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);
• \. Grade 2 or above toxicity from prior treatment that has not resolved (excluding anemia, alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity)
• Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jihui Hao, Dr

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Huikai Li, Dr

CONTACT

186 2222 8639; tjchlhk@126.com

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 5, 2024
• First Posted: May 8, 2024
• Study Start: April 27, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: May 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)