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Calcium Chloride Hexahydrate

This article explores a clinical trial investigating the use of Calcium Chloride Hexahydrate in combination with other treatments for patients with metastatic colorectal cancer. The study aims to evaluate the effectiveness and safety of calcium electroporation (Ca-EP) performed alongside irreversible electroporation (IRE) and immunotherapy using pembrolizumab. This innovative approach seeks to improve outcomes for patients with advanced colorectal cancer who have limited treatment options.

Table of Contents

What is Calcium Chloride Hexahydrate?

Calcium Chloride Hexahydrate is a chemical compound that contains calcium, chloride, and water molecules. In the medical context, it is being studied as part of a new treatment approach for patients with advanced colorectal cancer[1]. This compound is used in a procedure called calcium electroporation (Ca-EP), which is combined with other treatments to potentially improve outcomes for cancer patients.

Treatment Approach

The treatment approach being studied combines several methods:

  1. Calcium Electroporation (Ca-EP): This technique involves injecting calcium chloride hexahydrate into the tumor and then applying electrical pulses. This process helps to increase the amount of calcium inside cancer cells, which can lead to cell death[1].
  2. Irreversible Electroporation (IRE): This is a technique that uses electrical pulses to create permanent openings in cell membranes, leading to cell death[1].
  3. Immunotherapy: After the Ca-EP and IRE procedures, patients receive a drug called pembrolizumab. This is a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells[1].

This combination approach aims to not only directly attack the tumor but also stimulate the body’s immune response against cancer cells throughout the body.

Target Patient Group

This treatment is being studied for patients with:

  • Stage IV colorectal cancer: This means the cancer has spread from the colon or rectum to other parts of the body[1].
  • pMMR tumors: This refers to tumors with proficient mismatch repair, a characteristic that can make some cancers less responsive to certain treatments[1].
  • Cancer that has not responded to, or the patient cannot tolerate, standard chemotherapy options[1].

Potential Benefits

The researchers hope this treatment approach could offer several benefits:

  • Improved effectiveness against advanced colorectal cancer[1].
  • Stimulation of the body’s immune response against cancer cells[1].
  • Potential to treat tumors that haven’t responded to other therapies[1].
  • Possible improvement in survival rates and quality of life for patients[1].

Safety Considerations

As with any medical treatment, there are important safety considerations:

  • The treatment is not suitable for patients with certain heart conditions, epilepsy, or specific autoimmune diseases[1].
  • Patients need to have adequate kidney, liver, and bone marrow function to be eligible for the treatment[1].
  • The treatment may affect fertility, so patients of reproductive age need to use contraception during and after treatment[1].

Ongoing Research

A clinical trial is currently underway to study this treatment approach. The researchers are looking at several aspects:

  • How safe and tolerable the treatment is for patients[1].
  • How effective the treatment is at fighting the cancer[1].
  • How the treatment affects the immune system’s response to the cancer[1].
  • How long patients live without their cancer getting worse (progression-free survival)[1].
  • How long patients survive overall[1].
  • How the treatment affects patients’ quality of life[1].

It’s important to note that this is a Phase II study, which means the treatment is still in the research phase and is not yet approved for general use. The results of this study will help determine if this approach could become a new treatment option for patients with advanced colorectal cancer in the future.

Aspect Details
Study Type Phase 2 clinical trial
Main Objective Evaluate efficacy and safety of Ca-EP with IRE followed by pembrolizumab
Target Population Adults with stage IV, non-resectable pMMR colorectal cancer
Key Inclusion Criteria Age ≥18, adequate organ function, at least two metastatic tumors
Key Exclusion Criteria Prior immune checkpoint inhibitor treatment, certain cardiac conditions
Primary Endpoint Safety and tolerability of the combination therapy
Secondary Endpoints Systemic response, tumor response, survival outcomes, quality of life
Calcium Chloride Hexahydrate Usage Maximum 3 millimoles daily dose, 1-day treatment period

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to determine the effectiveness and safety of combining calcium electroporation (Ca-EP) with irreversible electroporation (IRE) and immunotherapy using pembrolizumab in patients with metastatic colorectal cancer.
  • Who is eligible to participate in this trial? Eligible participants are adults (18 years or older) with stage IV, non-resectable pMMR colorectal cancer. They must have at least two metastatic tumors, adequate organ function, and meet specific criteria regarding previous treatments and disease characteristics.
  • What treatments are being used in this clinical trial? The trial combines three main treatments: Calcium Chloride Hexahydrate for calcium electroporation (Ca-EP), irreversible electroporation (IRE), and immunotherapy with pembrolizumab (a PD-1 inhibitor).
  • What are the main outcomes being measured in this trial? The primary outcomes include evaluating the safety and tolerability of the combination therapy. Secondary outcomes involve assessing the systemic response, tumor response, progression-free survival, overall survival, and quality of life.
  • How long is the treatment period for Calcium Chloride Hexahydrate? The maximum treatment period for Calcium Chloride Hexahydrate is 1 day, with a maximum daily dose of 3 millimoles.

Ongoing Clinical Trials on Calcium Chloride Hexahydrate

  • Study on Calcium Chloride Hexahydrate, Irreversible Electroporation, and Pembrolizumab for Patients with Metastatic Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Calcium electroporation (Ca-EP): A treatment method that uses calcium and electrical pulses to increase the uptake of calcium into cancer cells, potentially leading to cell death.
  • Irreversible electroporation (IRE): A non-thermal tumor ablation technique that uses short electrical pulses to create permanent pores in cell membranes, leading to cell death.
  • Pembrolizumab: An immunotherapy drug that belongs to a class called PD-1 inhibitors, which help the immune system recognize and attack cancer cells.
  • pMMR: Proficient mismatch repair, referring to tumors with normal DNA repair mechanisms, which are typically less responsive to certain immunotherapies.
  • Metastatic colorectal cancer: Cancer that has spread from the colon or rectum to other parts of the body.
  • ECOG performance status: A scale used to assess how a patient's disease affects their daily living abilities and determine appropriate treatment and prognosis.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure if tumors are responding to treatment.
  • Progression-free survival: The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival: The length of time from the start of treatment or diagnosis that patients are still alive.
  • Quality of life: A measure of an individual's well-being and ability to carry out daily activities while dealing with a medical condition or its treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-calcium-chloride-hexahydrate-irreversible-electroporation-and-pembrolizumab-for-patients-with-metastatic-colorectal-cancer/