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

Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869474
• Other study ID #: 2022-219
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 2027

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Jia Yi Ma, M.D
• Phone: +8613621819595
• Email: 504043536[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Iodine125-Seeds implantation
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation

Drug:
• Gem/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

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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.	48 months
Secondary	Incidence and severity of Adverse events (AEs)	AEs are graded and reported using The CTCAE version 5.0.	48 months
Secondary	Progression-free survival (PFS)	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.	48 months
Secondary	Overall Response Rate (ORR)	ORR is defined as the percentage of patients with an investigator-assessed complete (CR) or partial response (PR) according to RECIST v1.1.	48 months
Secondary	CA19-9 response	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.	48 months
Secondary	Metabolic response	Metabolic response is evaluated by PET/CT according to EORTC criteria.	from baseline to the end of 2nd chemotherapy cycle
Secondary	Visual analog scale (VAS)	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).	48 months