AI-Driven Chlorine Dioxide Injections Claimed to Destroy Tumors: Science, Safety, and Regulatory Hurdles

Chinese inventor Xuewu Liu, who holds no formal medical credentials, is marketing an unproven cancer therapy that uses highly concentrated chlorine dioxide solutions injected directly into tumors. Backed by a self-taught AI algorithm that he claims optimizes dose and placement, Liu charges patients up to $20,000 per treatment. While he currently operates informally in China and through a German clinic, Liu and his new U.S. partner—a former pharmaceutical executive—are pushing to bring the procedure stateside, banking on the political climate shift following Robert F. Kennedy Jr.’s appointment as U.S. Health Secretary.

Background of the Treatment

Liu’s protocol combines two claims: (1) artificial intelligence can analyze CT/PET imaging to calculate the precise intratumoral volume and ClO₂ concentration needed to oxidize malignant cells, and (2) direct injections of 20,000 parts per million (ppm) chlorine dioxide will selectively ablate tumors. In contrast, FDA-approved water disinfection uses ≈1 ppm ClO₂. Liu produces his reagent in a Beijing apartment by mixing citric acid with sodium chlorite, though he reports a near-fatal explosion in early 2025.

Technical Overview of Chlorine Dioxide Chemistry

Chlorine dioxide (ClO₂) is a high-oxidation–potential gas (E° = +0.954 V) widely used in industrial bleaching and municipal water treatment. In aqueous solution, ClO₂ generates reactive oxygen species (ROS) that non-specifically oxidize proteins, lipids, and nucleic acids. Proposed mechanism:

ClO₂ + e^– → ClO₂^– (radical) → ROS cascade → cellular damage

However, at therapeutic bolus doses (>10,000 ppm), ClO₂ also risks hemolysis, endothelial injury, and chemical burns. Standard preclinical protocols demand GLP-compliant toxicology: determination of maximum tolerated dose (MTD), no observed adverse effect level (NOAEL), pharmacokinetics (PK), and biodistribution studies in multiple species. Liu has published only unreviewed preprints and WhatsApp screenshots.

Clinical Anecdotes and Reported Outcomes

To date, Liu claims 20 human treatments across China and Germany. Details are anecdotal:

1. A U.K. patient self-administered intratumoral injections and experienced excruciating pain lasting days, followed by accelerated tumor growth and suspected metastasis to skin layers.
2. At the German CMC Rheinfelden clinic, a patient treated for a vaginal tumor reported post-injection swelling and urinary retention–type complications.
3. Several U.S. patients have signed advocacy letters but none have completed an FDA-approved investigational new drug (IND) protocol.

“Screenshots of WhatsApp chats with patients or their doctors is not evidence of efficacy. Until appropriate, peer-reviewed studies are published, no patients should be treated outside of registered clinical trials,” says Dr. Alex Morozov, oncologist with trial experience at Pfizer.

Regulatory and Legal Landscape

In the U.S., ClO₂ injections would require an Investigational New Drug (IND) application with the FDA. Advertising unproven therapies breaches FDA’s pre-approval promotion rules (§502(n) of the Food, Drug, and Cosmetic Act). The Right to Try Act does not apply, as ClO₂ is not an FDA-recognized investigational drug with Phase I data. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) mandates ethics committee approval and compliance with the EU Clinical Trials Regulation (CTR).

Impact of Robert F. Kennedy Jr.’s Appointment

Kennedy’s “Make America Healthy Again” platform emphasizes patient choice and alternative therapies. Critics warn that his tenure could lower thresholds for compassionate-use approvals. The FDA’s archival removal of a ClO₂ warning page—ostensibly routine—has been seized upon by the “bleach therapy” community as de-facto endorsement.

Deeper Analysis: Toxicology and Safety Profile

Published animal data for ClO₂ show inhalation LC₅₀ in rats of 290 ppm over an hour. Intravenous LD₅₀ in rodents is estimated at ~150 mg/kg. Intratumoral injection bypasses first-pass metabolism, delivering a near-lethal bolus to local tissues. Without dose-escalation studies, the safety margin is unknown. Expected adverse events include chemical necrosis, hemorrhage, systemic oxidative stress, and multi-organ failure when ClO₂ diffuses into circulation.

Deeper Analysis: Ethical Considerations in Compassionate Use

Ethical frameworks (Declaration of Helsinki, Belmont Report) require Institutional Review Board (IRB) oversight, informed consent, and a Data Safety Monitoring Board (DSMB). In China, off-label or experimental treatments sometimes occur under “compassionate use,” but U.S. and EU standards demand transparent risk-benefit analyses. Bypassing these safeguards puts vulnerable patients at risk of exploitation and harm.

Deeper Analysis: Future Outlook and Recommendations

Given the rise of ROS-based ablation research—e.g., photodynamic therapy (PDT) and oncolytic viruses like T-VEC—the medical community should critically evaluate ClO₂ in controlled environments. Recommended steps:

• Independent chemical analysis of Liu’s reagent for purity and byproducts.
• GLP-compliant preclinical toxicology and pharmacodynamics in multiple species.
• Phase I clinical trial with DSMB oversight and IRB approval.
• Publication in peer-reviewed oncology journals and presentations at AACR or ASCO.

Conclusion

While the promise of an AI-optimized, intratumoral bleach therapy captures headlines, there is no credible scientific evidence that high-concentration chlorine dioxide injections selectively destroy cancer cells without unacceptable collateral damage. Until rigorous preclinical and clinical data emerge, physicians and patients should approach these claims with extreme caution.