Clinical trial · Interventional
Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): For tumor locates away from GI the planned enrolled patient had been completed, but for tumor locates closely to GI only 6 patients had been enrolled because not many eligible patients were available.
Summary
Brief summary (as posted)
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon-ion radiotherapy for tumor adjacent to GI | Radiation | — | UNRESOLVED |
| carbon-ion radiotherapy for tumor away from GI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- carbon-ion radiotherapy for tumor away from GI
- description
- For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels \[55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx\] are planned within the Phase I part.
- interventionNames
- Radiation: carbon-ion radiotherapy for tumor away from GI
- type
- EXPERIMENTAL
- label
- carbon-ion radiotherapy for tumor adjacent to GI
- description
- For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.
- interventionNames
- Radiation: carbon-ion radiotherapy for tumor adjacent to GI
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases (AASLD)-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein (AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association; 2. no clinically distant metastasis; 3. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm; 4. age ≥ 18 and \<80 years of age; 5. Karnofsky Performance Score ≥ 70; 6. No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial; 7. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial; Exclusion Criteria: 1. Distant metastasis (M1); 2. maximal tumor size is more than 12 cm; 3. tumor invading adjacent gastrointestine (T4); 4. Child push score B or C; 5. Previous hepatic radiotherapy; 6. Severe systemic disorders; 7. Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer; 8. Non conformity of the radiotherapy dose distribution when compared to the dose constraints; 9. Psychiatric disorders or any other condition that can make unreliable the informed consent;
References
Publications (0)
Data not yet available