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Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis

NCT06405685 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-08

No results posted yet for this study

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

Interventions

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 criteria of resection and underwent surgery.

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) 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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Jihui Hao, Dr · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06405685 on ClinicalTrials.gov