Metastatic Pancreatic CancerNCT05869474
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
A study testing Iodine125-Seeds implantation and Gem/nab-P Chemotherapy in people with Metastatic Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Iodine125-Seeds implantation and Gem/nab-P Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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;
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kai Xuan Wang, M.D contact
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Kaixuan Wang, MD, 86-21-31161353, wangkaixuan224007@sina.com
About this study
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
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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Iodine125-Seeds implantation, Gem/nab-P Chemotherapy
- Keywords
- iodine 125, EUS-guided implantation, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine125-Seeds implantationProcedure or surgery
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
Gem/nab-P ChemotherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| I125-AG | Experimental | 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. Receives: Procedure: Iodine125-Seeds implantation; Drug: Gem/nab-P Chemotherapy |
| AG | Active comparator | Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle. Receives: Drug: Gem/nab-P Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (6)
Incidence and severity of Adverse events (AEs)
AEs are graded and reported using The CTCAE version 5.0.
Measured: 48 months
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.
Measured: 48 months
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.
Measured: 48 months
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.
Measured: 48 months
Metabolic response
Metabolic response is evaluated by PET/CT according to EORTC criteria.
Measured: from baseline to the end of 2nd chemotherapy cycle
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).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Aug 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao Shen Li, M.D, Principal investigator, Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869474
- Sponsor's protocol ID
- 2022-219
- Status last verified
- Aug 2023
- First submitted
- 11 May 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05869474
- Acronym / sponsor ID
- 2022-219
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- iodine 125, EUS-guided implantation, chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I125-AG | Experimental | Procedure: Iodine125-Seeds implantation, Drug: Gem/nab-P ChemotherapyParticipants 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. |
| AG | Active comparator | Drug: Gem/nab-P ChemotherapyParticipants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine125-Seeds implantationEndoscopic ultrasound-guided intratumoral iodine125-Seeds implantation | Procedure or surgery | I125-AG |
| Gem/nab-P Chemotherapynab-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 | Drug | AG, I125-AG |
Primary outcome
Overall survival (OS)
Time frame: 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.
6 secondary outcomes
Incidence and severity of Adverse events (AEs)
Time frame: 48 months
Progression-free survival (PFS)
Time frame: 48 months
Overall Response Rate (ORR)
Time frame: 48 months
CA19-9 response
Time frame: 48 months
Metabolic response
Time frame: from baseline to the end of 2nd chemotherapy cycle
Visual analog scale (VAS)
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai Xuan Wang, M.D contact
Zhao Shen Li, M.D principal investigator
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine125-Seeds implantation and Gem/nab-P Chemotherapy in people with Metastatic Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Yi Ma, M.D (+8613621819595, 504043536@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.