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NCT05869474 | RECRUITING | Metastatic Pancreatic Cancer

Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
Sponsor:

Changhai Hospital

Information provided by (Responsible Party):

Damn

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.

Condition or disease

Metastatic Pancreatic Cancer

Intervention/treatment

Iodine125-Seeds implantation

Gem/nab-P Chemotherapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 206 participants
Masking : DOUBLE
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.
Primary Purpose : TREATMENT
Official Title : Endoscopic Ultrasound-guided Intratumoral Iodine125-Seeds Implantation Combined With Gem/Nab-P Chemotherapy Versus Gem/Nab-P Alone for Metastatic Pancreatic Carcinoma: a Randomized, Controlled, Trial
Actual Study Start Date : 2023-08-01
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma

Location Details

NCT05869474

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Locations

RECRUITING

China, Shanghai

Changhai Hospital

Shanghai, Shanghai, China, 200433