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

Primary Purpose

Metastatic Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iodine125-Seeds implantation
Gem/nab-P Chemotherapy
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring iodine 125, EUS-guided implantation, chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled) 18 to 80 years old; 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. No treatment history of chemotherapy, radiotherapy, or surgery Expected survival > 6 months ECGO score of 0-2 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) Signed written informed consent; Exclusion Criteria: Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant or breastfeeding Presence of brain metastases Presence of deep vein thrombosis or pulmonary embolism Presence of HIV, HBV, HCV infection or other uncontrollable active infection Hypersensitivity to chemotherapy drugs History of other malignancies within 5 years Peripheral neuropathy or interstitial lung disease within 5 years Patient is enrolled in any other clinical protocol or investigational trial.

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I125-AG

AG

Arm Description

Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle will be conducted.

Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence and severity of Adverse events (AEs)
AEs are graded and reported using The CTCAE version 5.0.
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.
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.
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.
Metabolic response
Metabolic response is evaluated by PET/CT according to EORTC criteria.
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).

Full Information

First Posted
May 11, 2023
Last Updated
August 3, 2023
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05869474
Brief Title
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
iodine 125, EUS-guided implantation, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I125-AG
Arm Type
Experimental
Arm Description
Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle will be conducted.
Arm Title
AG
Arm Type
Active Comparator
Arm Description
Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle.
Intervention Type
Procedure
Intervention Name(s)
Iodine125-Seeds implantation
Intervention Description
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
Intervention Type
Drug
Intervention Name(s)
Gem/nab-P Chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
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.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Incidence and severity of Adverse events (AEs)
Description
AEs are graded and reported using The CTCAE version 5.0.
Time Frame
48 months
Title
Progression-free survival (PFS)
Description
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.
Time Frame
48 months
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of patients with an investigator-assessed complete (CR) or partial response (PR) according to RECIST v1.1.
Time Frame
48 months
Title
CA19-9 response
Description
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.
Time Frame
48 months
Title
Metabolic response
Description
Metabolic response is evaluated by PET/CT according to EORTC criteria.
Time Frame
from baseline to the end of 2nd chemotherapy cycle
Title
Visual analog scale (VAS)
Description
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).
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled) 18 to 80 years old; 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. No treatment history of chemotherapy, radiotherapy, or surgery Expected survival > 6 months ECGO score of 0-2 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) Signed written informed consent; Exclusion Criteria: Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant or breastfeeding Presence of brain metastases Presence of deep vein thrombosis or pulmonary embolism Presence of HIV, HBV, HCV infection or other uncontrollable active infection Hypersensitivity to chemotherapy drugs History of other malignancies within 5 years Peripheral neuropathy or interstitial lung disease within 5 years Patient is enrolled in any other clinical protocol or investigational trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Yi Ma, M.D
Phone
+8613621819595
Email
504043536@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Xuan Wang, M.D
Email
wangkaixuan224007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Shen Li, M.D
Organizational Affiliation
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaixuan Wang, MD
Phone
86-21-31161353
Email
wangkaixuan224007@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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