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Prospective clinical study of ketogenic treatment for advanced hepatocellular carcinoma

Prospective clinical study of ketogenic treatment for advanced hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028108
Enrollment
Unknown
Registered
2019-12-12
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Sponsors

Drum Hospital of medical school of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Tumor histological examination confirms advanced HCC, non-surgical resection of hepatocellular carcinoma, visible lesions larger than 1 cm, able to tolerate and complete TACE, radiotherapy, targeted therapy; 2. Age 18-70 years, regardless of gender; 3. Organ status allows clinical trials: Child score =2.5x10^9/L, PLT >=60x10^9/L, Hb >=9.0 g/dL, MID >=1.0x10^9/L; LY >=0.4x10^9/L, LY% >=15%; 4. Blood biochemistry: serum Alb >=30 g/L, serum lipase and amylase 90% (at room temperature); ejection fraction (EF)> 55%; 6. No bleeding and coagulopathy; 7. No contrast agent allergy; 8. Contraception: use of contraception during clinical trials; 9. Sufficient peripheral blood can be obtained through the vein, and there are no other contraindications for lymphocyte collection; 10. Karnofsky functional status score> 60%; Informed consent for one year of ketogenic treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes; 2. History of hypoglycemia; 3. Patients with porphyria; 4. Patients with pyruvate carboxylase deficiency; 5. Patients with diseases of fatty acid mitochondrial transport disorder; 6. Patients with ß-oxidation deficiency and some special mitochondrial diseases; 7. Patients with severe kidney disease; 8. Imaging and histological diagnosis of extrahepatic metastases or other tumors; 9. Accept liver resection and liver transplantation patients; 10. Patients whose heart and lung function cannot tolerate TACE and radiotherapy; 11. Pregnant or lactating women; 12. Uncontrolled symptoms or other diseases including but not limited to infection, congestive heart failure, unstable angina pectoris, arrhythmia, mental illness or restricting the social environment that meets the requirements or the attending doctor thinks it will bring unpredictable risks; 13. Patients participating in other clinical trials; 14. Other accompanying anti-tumor treatments; 15. The investigator assesses that the patient is unable or unwilling to comply with the requirements of the research protocol; 16. Researchers consider other reasons unsuitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
tumor size;tumor metastasis rate;lifetime;

Secondary

MeasureTime frame
serum AFP;

Countries

China

Contacts

Public ContactDecai Yu

Drum Hospital of Medical School of Nanjing University

yudecai@nju.edu.cn+86 13701585023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026