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

Phase 2

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: nimotuzumab; Drug: AG chemotherapy

• Registration Number: NCT06404840
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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 sca...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-05-06
• Status Verified: 2024-05
• 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: 2025-03-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

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

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.

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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:
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  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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AG+nimotuzumab	AG chemotherapy	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).
AG+nimotuzumab	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).

Primary Outcome Measures

Name	Time	Method
AEs	3month	Primary endpoints were adverse events (AEs),

Secondary Outcome Measures

Name	Time	Method
R0 resection rates	3month	R0 resection rates
surgical conversion rates	3month	surgical conversion rates
pathological complete response (pCR) rate	3month	pathological complete response (pCR) rate

Trial Locations

Locations (1)

Tianjin Cancer Hospital Airport Hospital; 🇨🇳 Tianjin, Tianjin, China