Hepatocellular Carcinoma
Conditions
Keywords
Stereotactic body radiotherapy, Micro vascular invasion, Narrow resection margin
Brief summary
Positive micro vascular invasion in early stage hepatocellular carcinoma(HCC) leads to early recurrence after surgery. Adjuvant external radiotherapy will be applied in those patients to see if disease free survival and overall survival could be approved.
Detailed description
Hepatocellular carcinoma(HCC) ranks the 6th most common cancer and is the 2nd leading cause of cancer-related death globally. Surgical resection remains the most efficient therapy in early stage. Though an anatomical resection of tumor lead to an up to 70% 5-year overall survival, the existence of micro vascular invasion(MVI) caused early recurrence. Stereotactic body radiation therapy (SBRT) has been proved to be efficient in treating vascular tumor thrombosis. The investigators tried to implement this technique in adjuvant setting for HCC after surgery with MVI. Participants with early stage HCC whose tumor locates closely to the main intrahepatic vascular will be regarded as potentially-not-enough-surgical-margin candidates. Surgical resection will be carried out as scheduled and an additional silver clip will be put into the margin. Postoperative pathological examination will detect micro vascular invasion or daughter nodule. MVI-positive candidates will be eligible for enrollment. Eligible participants will be randomized to two groups, SBRT group and surgery-alone(SA) group with 1-to-1 ratio. Participants in SBRT group will receive a 35Gy limited resection margin parenchyma SBRT after surgery, while participants in SA group just get surgery. Radiation related adverse events (AE) or reaction will be recorded and intervened necessarily. All participants will be followed up by investigators every three months. DFS, OS, and AEs are end points in this study.
Interventions
RADIATIONStereotactic radiotherapy
Radiation using stereotactic radiotherapy device.
Sponsors
Eastern Hepatobiliary Surgery Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Adjuvant SBRT after surgery group vs. surgery alone group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. solitary nodule; 2. tumor adjacent to the main trunk of hepatic vein, cava vena, or to the major branch of portal vein (including the lobar branch at least); 3. macro-vascular negative; 4. no previous treatment before surgery; 5. no previous hepatic surgery; 6. Child-Pugh score A for hepatic function.
Exclusion criteria
1. spontaneous rupture; 2. pathologically proved positive resection margin; 3. severe cirrhosis with hypersplenism or esophageal and gastric varices; 4. 4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver; 5. postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Without Recurrence (Disease-free). | DFS rate at 5-years after randomization. | Participants will be monitored for recurrence(disease) since enrollment. DFS was defined as time interval from randomization to the first recurrence. The unit of measure was month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) Rate. | OS rate at 5-years from randomization. | OS was defined as time interval from randomization to death. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Occured Adverse Events(AE) | AE will be evaluated up to 3 months after radiotherapy in SBRT group | AE was defined as side effect related to the radiotherapy |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SBRT Group Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.
Stereotactic radiotherapy: Radiation using stereotactic radiotherapy device. | 38 |
| Surgery Alone Group Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma. | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | SBRT Group | Surgery Alone Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 35 Participants | 69 Participants |
| Hepatitis Virus | 38 Number of Participants With Hepatitis Vi | 38 Number of Participants With Hepatitis Vi | 76 Number of Participants With Hepatitis Vi |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 38 Participants | 76 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 38 participants | 38 participants | 76 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 33 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 12 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
Participants Without Recurrence (Disease-free).
Participants will be monitored for recurrence(disease) since enrollment. DFS was defined as time interval from randomization to the first recurrence. The unit of measure was month.
Time frame: DFS rate at 5-years after randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT Group | Participants Without Recurrence (Disease-free). | 16 Participants |
| Surgery Alone Group | Participants Without Recurrence (Disease-free). | 28 Participants |
Secondary
Overall Survival (OS) Rate.
OS was defined as time interval from randomization to death.
Time frame: OS rate at 5-years from randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT Group | Overall Survival (OS) Rate. | 29 Participants |
| Surgery Alone Group | Overall Survival (OS) Rate. | 20 Participants |
Other Pre-specified
Number of Participants Occured Adverse Events(AE)
AE was defined as side effect related to the radiotherapy
Time frame: AE will be evaluated up to 3 months after radiotherapy in SBRT group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBRT Group | Number of Participants Occured Adverse Events(AE) | 12 Participants |
| Surgery Alone Group | Number of Participants Occured Adverse Events(AE) | 0 Participants |