Nimotuzumab Plus AG In Pancreatic Cancer With Liver Metastasis

Study Overview

Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis

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.

This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (gemcitabine and nab-paclitaxel) 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 resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

Pancreatic Cancer

DRUG: Nimotuzumab
DRUG: AG

IST-Nim-PC-5

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-05
First Submitted that Met QC Criteria 2024-05-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-08
First Posted (ACTUAL) 2024-05-08	Results First Posted N/A	Last Verified 2023-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nimotuzumab+AG 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 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 DRUG: AG 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) administrat

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nimotuzumab+AG

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

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

DRUG: AG

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) administrat

Primary Outcome Measures	Measure Description	Time Frame
R0 resection rate	The Proportion of patients who achieved R0 resection (incisal edge>1cm)	Up to 6 months

Secondary Outcome Measures	Measure Description	Time Frame
resection rate	The proportion of patients who underwent surgery.	Up to 18 months
overall survival (OS)	The time from the beginning of treatment to death due to any cause.	Up to 18 months
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.	Up to 18 months
tumor-related markers	To explore the influence of tumor-related markers (such as CA199,EGFR) on prognosis.	Up to 18 months
adverse events	Frequency and severity of adverse events.	Up to 30 days after last administration

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Huikai Li, Dr

Phone Number: 186 2222 8639

Email: tjchlhk@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

1. Age 18-75 years old, gender unlimited;
2. Histologically or cytologically confirmed pancreatic cancer with liver metastasis;
3. Pancreatic cancer with liver metastasis, which is considered to be potentially resectable judged by a multidisciplinary team;
4. Receive nimotuzumab-based conversion therapy for voluntary;
5. No prior tumor systemic therapy;
6. Measurable disease according to RECIST criteria v1.1;
7. 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;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Life expectancy is expected to be ≥3 months;
10. Fertile subjects are willing to take contraceptive measures during the study period.
11. Good compliance and signed informed consent voluntarily.

1. Refuse chemotherapy or surgery;
2. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
4. 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;
5. Undergone major surgery within 30 days;
6. Use of EGFR-mab or EGFR-TKI within 30 days;
7. Known allergy to prescription or any component of the prescription used in this study;
8. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
9. Grade 2 or above toxicity from prior treatment that has not resolved (excluding anemia, alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity)
10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Jihui Hao, Dr, Tianjin Medical University Cancer Institute and Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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