Key facts about advanced colorectal cancer
- Stage 4 colorectal cancer five-year survival under standard care is approximately 14 percent
- Colorectal carcinoma cells over-express NaV1.5 sodium channels
- Liver and lung metastases are typical patterns; isolated bone-marrow infiltration is a separate consideration
Investigational targeted therapy
Targeted Osmotic Lysis (TOL) is a clinical-stage non-toxic targeted therapy that combines a cardiac glycoside drug with a pulsed electric field device. The mechanism exploits the documented voltage-gated sodium channel over-expression in colorectal cancer cells, which carry 10 to 50 times the channel density of normal tissue. Cancer cells take in sodium and water faster than they can expel, and rupture. Normal cells, with sparse channel expression, recover when the drug clears.
TOL has been the subject of 13 peer-reviewed publications, one foundational LSU patent, and human emergency-use and IRB-approved pilot studies including the 2021 cervical squamous cell carcinoma case (Current Oncology), the 2025 cutaneous squamous cell carcinoma case, and the 2025 malignant melanoma case (Annals of Oncology Case Reports).
TOL is investigational. It has not been approved by the FDA for the treatment of cancer. See /regulatory for the full investigational therapy statement.
Access pathways
Stage 3 and stage 4 colorectal cancer patients seeking investigational therapy can pursue access through three regulatory frameworks in the United States: clinical trial enrollment, the FDA Expanded Access program under 21 CFR Part 312 Subpart I, and the federal Right to Try Act of 2018. International partner clinical sites operate in Tijuana, Mexico under COFEPRIS authority, and in Australia under the TGA Special Access Scheme.
Detailed access guidance is available on /regulatory and /why-fixcancers.
Frequently asked questions
What treatment options exist for stage 4 colorectal cancer? Standard options include surgery, chemotherapy, radiation, hormone therapy where applicable, and immunotherapy. When standard options are exhausted, patients may consider clinical trials, FDA expanded access, the Right to Try Act, and investigational targeted therapies through partner clinical sites in the United States, Mexico, and Australia.
Is colorectal cancer eligible for Targeted Osmotic Lysis? Colorectal Cancer cells over-express voltage-gated sodium channels at the density required for Targeted Osmotic Lysis eligibility. Final eligibility requires biopsy confirmation and clinical review by the partner site's investigators.
How do I get a second opinion on colorectal cancer? Second opinions are routinely available through academic medical centers, NCI-designated comprehensive cancer centers, and patient navigation services. Request your pathology slides, imaging, and treatment summary before scheduling. FixCancers.com offers a written eligibility assessment process for stage 3 and stage 4 patients.
Submit your records for clinical eligibility review.
The clinical team reviews pathology, imaging, and treatment history. A clinician responds with a written eligibility assessment within three to five business days.
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