Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis

Phase 2

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Nimotuzumab; Drug: AG

• Registration Number: NCT06405685
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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) w...

Detailed Description

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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-04-27
• Status Verified: 2023-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab+AG	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.
Nimotuzumab+AG	Nimotuzumab	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.

Primary Outcome Measures

Name	Time	Method
R0 resection rate	Up to 6 months	The Proportion of patients who achieved R0 resection (incisal edge\>1cm)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China