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[188Re]-Bis(Perthiobenzoato)(Dithiobenzoato)Rhenium (Iii)

This article discusses a phase II clinical trial investigating the effectiveness of 188Re-SSS Lipiodol, a radiopharmaceutical containing [188Re]-Bis(Perthiobenzoato)(Dithiobenzoato)Rhenium (III), for treating non-operable hepatocellular carcinoma (liver cancer). The study aims to evaluate the efficacy of this treatment using Selective Internal Radiation Therapy (SIRT) in patients who cannot undergo surgery. The trial focuses on assessing tumor response, survival rates, and safety of this innovative approach for liver cancer patients with limited treatment options.

Table of Contents

What is 188Re-SSS Lipiodol?

188Re-SSS Lipiodol is a promising new treatment for patients with non-operable hepatocellular carcinoma, which is a type of liver cancer that cannot be surgically removed[1]. The active substance in this treatment is [188Re]-BIS(PERTHIOBENZOATO)(DITHIOBENZOATO)RHENIUM (III), a chemical compound that contains a radioactive form of rhenium[1].

How Does It Work?

This treatment works through a process called Selective Internal Radiation Therapy (SIRT). In this procedure, the radioactive substance is injected directly into the arteries that supply blood to the liver tumor[1]. The radiation emitted by the rhenium compound helps to destroy cancer cells while minimizing damage to healthy liver tissue.

Who Can Benefit from This Treatment?

This treatment is specifically designed for patients with:

  • Non-operable hepatocellular carcinoma: This means the liver cancer cannot be surgically removed[1].
  • ECOG Performance Status 0-1: This indicates that the patient is either fully active or restricted in physically strenuous activity but able to carry out light work[1].
  • Tumor involvement less than 50% of the liver[1].
  • BCLC classification A to C: This refers to the Barcelona Clinic Liver Cancer staging system, which helps determine the extent of the disease[1].

However, this treatment may not be suitable for everyone. Patients with certain conditions, such as inadequate blood cell counts, liver or kidney function, or those who have recently undergone other treatments for liver cancer, may not be eligible[1].

The Treatment Process

The treatment involves:

  1. Pre-treatment assessment: Doctors will perform various tests to ensure you’re eligible for the treatment[1].
  2. Injection procedure: The 188Re-SSS Lipiodol is injected into the arteries feeding the liver tumor through a process called intraarterial use[1].
  3. Monitoring: After the treatment, you’ll be closely monitored for any side effects and to assess the treatment’s effectiveness[1].

Effectiveness of the Treatment

The ongoing clinical trial aims to evaluate how effective this treatment is. The main things they’re looking at include:

  • Objective response rate: This measures how well the tumor responds to treatment within 6 months[1].
  • Time to liver progression: This measures how long it takes for the liver cancer to start growing again[1].
  • Progression-free survival: This looks at how long patients live without their cancer getting worse[1].
  • Overall survival: This measures how long patients live after starting the treatment[1].

Potential Side Effects and Precautions

As with any medical treatment, there may be side effects. The clinical trial excludes patients with certain conditions to minimize risks. These include:

  • Pregnant or breastfeeding women[1]
  • Patients with other types of cancer[1]
  • Those with severe arterial problems or chronic respiratory insufficiency[1]

It’s important to discuss potential risks and side effects with your healthcare provider.

Ongoing Research and Future Prospects

This treatment is currently being studied in a Phase II clinical trial. This means it has already shown promise in earlier studies, and researchers are now looking at its effectiveness in a larger group of patients[1]. If the results are positive, it could become an important new option for patients with non-operable liver cancer.

As research continues, we may learn more about how effective this treatment is and who it might help the most. It’s an exciting development in the field of liver cancer treatment, offering hope to patients who may have limited options.

Aspect Details
Study Type Phase II clinical trial
Drug Name 188Re-SSS Lipiodol
Active Substance [188Re]-Bis(Perthiobenzoato)(Dithiobenzoato)Rhenium (III)
Target Condition Non-operable hepatocellular carcinoma
Treatment Method Selective Internal Radiation Therapy (SIRT)
Administration Route Intraarterial use
Maximum Dose 3.7 GBq/g
Primary Endpoints Objective response rate, time to liver progression, progression-free survival, overall survival
Key Eligibility Criteria ECOG 0-1, non-operable HCC, tumor involvement <50% of liver, Child-Pugh A or B7 cirrhosis
Follow-up Duration Up to 24 months after radioembolization

FAQ

  • What is the main objective of this clinical trial? The main objective of this clinical trial is to evaluate the efficacy of 188Re-SSS Lipiodol Selective Internal Radiation Therapy in patients with non-operable hepatocellular carcinoma (liver cancer).
  • Who is eligible to participate in this trial? Eligible participants include adults with non-operable hepatocellular carcinoma, ECOG Performance Status 0-1, at least one measurable lesion, tumor involvement less than 50% of the liver, and compensated cirrhosis (if present). Patients must also meet other specific criteria and provide informed consent.
  • What is 188Re-SSS Lipiodol? 188Re-SSS Lipiodol is a radiopharmaceutical solution for injection containing [188Re]-Bis(Perthiobenzoato)(Dithiobenzoato)Rhenium (III). It is used in Selective Internal Radiation Therapy for treating liver cancer.
  • How is the treatment administered? The treatment is administered through intraarterial use, which means it is injected directly into the arteries supplying blood to the liver tumors. The maximum daily dose is 3.7 GBq/g (gigabecquerel/gram).
  • What are the main outcomes being measured in this trial? The main outcomes include objective response rate within 6 months, best overall responses at various time points, time to liver progression, progression-free survival, overall survival, and biological response rate based on alpha-fetoprotein (AFP) levels.

Ongoing Clinical Trials on [188Re]-Bis(Perthiobenzoato)(Dithiobenzoato)Rhenium (Iii)

  • Study on the Effectiveness of 188Re-SSS Lipiodol Therapy for Patients with Non-Operable Liver Cancer

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Hepatocellular carcinoma: A type of liver cancer that starts in the main cell type of the liver (hepatocytes).
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • BCLC classification: Barcelona Clinic Liver Cancer staging system used to determine the extent of liver cancer and guide treatment decisions.
  • Child-Pugh score: A scoring system used to assess the prognosis of chronic liver disease and cirrhosis.
  • mRECIST criteria: Modified Response Evaluation Criteria in Solid Tumors, used to assess tumor response to treatment in liver cancer.
  • Selective Internal Radiation Therapy (SIRT): A treatment that delivers radiation directly to liver tumors through the bloodstream.
  • Alpha-fetoprotein (AFP): A protein produced by liver cancer cells, used as a tumor marker to monitor treatment response.
  • Radioembolization: A procedure that combines embolization and radiation therapy to treat liver tumors.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the disease getting worse.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-188re-sss-lipiodol-therapy-for-patients-with-non-operable-liver-cancer/