Pancreatic Cancer
Conditions
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 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.
Interventions
DRUGnimotuzumab
nimotuzumab (400 mg, iv, d1, qw)
DRUGAG chemotherapy
(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs | 3month | Primary endpoints were adverse events (AEs), |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical conversion rates | 3month | surgical conversion rates |
| R0 resection rates | 3month | R0 resection rates |
| pathological complete response (pCR) rate | 3month | pathological complete response (pCR) rate |
Countries
China
Outcome results
None listed