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NCT Number: NCT05869474

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Kaixuan Wang, MD

CONTACT

[email protected]

86-21-31161353

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iodine125-Seeds implantation

Procedure

Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation

Gem/nab-P Chemotherapy

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. Incidence and severity of Adverse events (AEs)

    Time frame: 48 months

    AEs are graded and reported using The CTCAE version 5.0.

  2. Progression-free survival (PFS)

    Time frame: 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.

  3. Overall Response Rate (ORR)

    Time frame: 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.

  4. CA19-9 response

    Time frame: 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.

  5. Metabolic response

    Time frame: from baseline to the end of 2nd chemotherapy cycle

    Metabolic response is evaluated by PET/CT according to EORTC criteria.

  6. Visual analog scale (VAS)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Yi Ma, M.D

CONTACT

[email protected]

+8613621819595

Kai Xuan Wang, M.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 22, 2023
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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