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Trial Title:
Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study
NCT ID:
NCT06404840
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
nimotuzumab
Description:
nimotuzumab (400 mg, iv, d1, qw)
Arm group label:
AG+nimotuzumab
Intervention type:
Drug
Intervention name:
AG chemotherapy
Description:
(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)
Arm group label:
AG+nimotuzumab
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 scarce clinical data regarding its efficacy in conjunction with AG for
treating PCLM. This study aims to evaluate the safety and efficacy of incorporating
nimotuzumab with AG for PCLM.
Criteria for eligibility:
Criteria:
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.
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Cancer Hospital Airport Hospital
Address:
City:
Tianjin
Zip:
300308
Country:
China
Status:
Recruiting
Contact:
Last name:
Huikai Li, Doctor
Phone:
18622228639
Email:
tjchlhk@126.com
Contact backup:
Last name:
Yang Liu, MD
Phone:
17694950696
Email:
tjchlhk@126.com
Start date:
May 6, 2022
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06404840
