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A prospective observational study on evaluating the efficacy and side-effects of radiotherapy for hepatocellular carcinoma based on the radiomics of gadoxetate disodium-enhanced hepatic MRI

A prospective observational study on evaluating the efficacy and side-effects of radiotherapy for hepatocellular carcinoma based on the radiomics of gadoxetate disodium-enhanced hepatic MRI

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064188
Enrollment
Unknown
Registered
2022-09-29
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Hepatocellular Carcinima

Interventions

The whole group:Radiotherapy

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, gender is not limited; 2. ECOG 0-1 points; 3. Hepatocellular carcinoma confirmed by clinical diagnosis or pathology; 4. Child-pugh score of liver function is A or B (= 90 g/L, ANC >= 1.5 x 10^9/L, PLT >= 75 x 10^9/L, WBC >= 3.0 x 10^9/L; creatinine <= 1.5 x ULN; 8. The liver can be scanned with enhanced MRI within 2 weeks before radiotherapy, and the effect of enhanced MRI can be re-examined 1-3 months after radiotherapy; 9. Patients with active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be < 500 IU/mL (if the research center only has a copy/mL testing unit, it must be < 2500 copy/mL ), and receiving anti-HBV therapy (treatment according to local standard of care, such as entecavir) for at least 14 days prior to the start of study treatment and willing to receive antiviral therapy throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive Patients must receive antiviral therapy according to local standard treatment guidelines and liver function within CTCAE grade 1 elevation; 10. Women of childbearing age (usually 15-49 years old) must have a negative pregnancy test (serum or urine) result within 14 days before enrollment; for men, they should agree to use appropriate methods of contraception during the observation period; 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Those who are unable to receive MRI examination or are allergic to gadoxetate disodium; 2. The tumor is close to the organs at risk such as the intestine, and it is difficult to tolerate radiotherapy; the residual liver volume is less than 700ml, and it is difficult to tolerate radiotherapy; 3. Past or current combined with other malignant tumor diseases; 4. Patients with severe cardiopulmonary insufficiency who cannot tolerate radiotherapy.

Design outcomes

Primary

MeasureTime frame
Imagine characteristics;

Countries

China

Contacts

Public ContactWeihu Wang

Peking University Cancer Hospital

wangweihu88@163.com+86 10 88196687

Outcome results

None listed

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