Metastatic Pancreatic Cancer
Conditions
Keywords
iodine 125, EUS-guided implantation, chemotherapy
Brief summary
The goal of this clinical trial is to evaluate the clinical efficacy and safety of endoscopic ultrasonography (EUS)-guided radioactive iodine 125 seeds in combination with AG regimen chemotherapy for the treatment of metastatic pancreatic cancer. The main questions it aims to answer are: * whether the combination of minimally invasive endoscopy-guided local radiation therapy with chemotherapy may improve overall survival * the adverse events of the combination therapy Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gem/nab-P given on days 1 and 8 of each 21-day cycle will be conducted. Researchers will compare the I125+AG group with the group that takes AG chemotherapy alone to see if the overall survival can be improved.
Interventions
PROCEDUREIodine125-Seeds implantation
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
DRUGGem/nab-P Chemotherapy
nab-paclitaxel (125 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8 every 3 weeks
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Patients will be randomly assigned(1:1) to the two treatment groups by an independent staff who is not involved in the treatment. The endoscopist and patient are not masked because they exactly know whether EUS-guided implantation is performed or not. Survival will be assessed by blinded researchers during follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled) 1. 18 to 80 years old; 2. Stage IV pancreatic ductal adenocarcinoma with distant metastases confirmed by clinical, imaging, and pathology, and the primary and metastatic mass can be measured on imaging. 3. No treatment history of chemotherapy, radiotherapy, or surgery 4. Expected survival \> 6 months 5. ECGO score of 0-2 6. Eligible for chemotherapy (white blood cell \> 3.5×109/L, neutrophil value \> 1.5×109/L, hemoglobin \> 80g/L, platelets \> 100×109/L, albumin \> 25g/L, alanine aminotransferase or aspartate aminotransferase ≤ 3 times the upper limit of normal and total bilirubin level ≤ 34.2umol/L, creatinine \< 176.8 umol/L, normal ECG) 7. Signed written informed consent;
Exclusion criteria
1. Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) 2. Pregnant or breastfeeding 3. Presence of brain metastases 4. Presence of deep vein thrombosis or pulmonary embolism 5. Presence of HIV, HBV, HCV infection or other uncontrollable active infection 6. Hypersensitivity to chemotherapy drugs 7. History of other malignancies within 5 years 8. Peripheral neuropathy or interstitial lung disease within 5 years 9. Patient is enrolled in any other clinical protocol or investigational trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 48 months | OS is defined as the time from the date of randomization to the date of death (any cause). Patients who are alive will be censored at the last known time that the patient was alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 48 months | PFS is defined as the time from the date of randomization to the date of objective disease progression according to RECIST 1.1 criteria or death (due to any cause),whichever occurs first. |
| Overall Response Rate (ORR) | 48 months | ORR is defined as the percentage of patients with an investigator-assessed complete (CR) or partial response (PR) according to RECIST v1.1. |
| Incidence and severity of Adverse events (AEs) | 48 months | AEs are graded and reported using The CTCAE version 5.0. |
| Metabolic response | from baseline to the end of 2nd chemotherapy cycle | Metabolic response is evaluated by PET/CT according to EORTC criteria. |
| Visual analog scale (VAS) | 48 months | Pain is scored according to a VAS score, with a score of 0 indicating no pain and a score of 10 indicating the most intense degree of pain (unbearable pain). |
| CA19-9 response | 48 months | CA19-9 response is defined as a decrease of CA19-9 concentration by 50% from the prespecified baseline concentration of 74 U/mL or more. |
Countries
China
Contacts
Primary ContactJia Yi Ma, M.D
Backup ContactKai Xuan Wang, M.D
Outcome results
None listed