Trial Outcomes & Findings for Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI (NCT NCT04891874)
NCT ID: NCT04891874
Last Updated: 2021-09-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
DFS rate at 5-years after randomization.
Results posted on
2021-09-10
Participant Flow
Participant milestones
| Measure |
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.
|
Surgery Alone Group
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI
Baseline characteristics by cohort
| Measure |
SBRT Group
n=38 Participants
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.
|
Surgery Alone Group
n=38 Participants
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Hepatitis Virus
|
38 Number of Participants With Hepatitis Vi
n=5 Participants
|
38 Number of Participants With Hepatitis Vi
n=7 Participants
|
76 Number of Participants With Hepatitis Vi
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SBRT Group
n=38 Participants
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.
|
Surgery Alone Group
n=38 Participants
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
|
|---|---|---|
|
Participants Without Recurrence (Disease-free).
|
16 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: OS rate at 5-years from randomization.OS was defined as time interval from randomization to death.
Outcome measures
| Measure |
SBRT Group
n=38 Participants
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.
|
Surgery Alone Group
n=38 Participants
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
|
|---|---|---|
|
Overall Survival (OS) Rate.
|
29 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: AE will be evaluated up to 3 months after radiotherapy in SBRT groupAE was defined as side effect related to the radiotherapy
Outcome measures
| Measure |
SBRT Group
n=38 Participants
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.
|
Surgery Alone Group
n=38 Participants
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
|
|---|---|---|
|
Number of Participants Occured Adverse Events(AE)
|
12 Participants
|
0 Participants
|
Adverse Events
SBRT Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Surgery Alone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SBRT Group
n=38 participants at risk
Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin. The AE like fatigue, vomitting, skin reaction and other items according to CTCAE5.0 will be recorded.
|
Surgery Alone Group
n=38 participants at risk
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
|
|---|---|---|
|
General disorders
Fatigue
|
23.7%
9/38 • Number of events 9 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
0.00%
0/38 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
2/38 • Number of events 2 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
0.00%
0/38 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
|
Gastrointestinal disorders
Dyspepsea
|
5.3%
2/38 • Number of events 2 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
0.00%
0/38 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
3/38 • Number of events 3 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
0.00%
0/38 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
|
Hepatobiliary disorders
Liver injury
|
5.3%
2/38 • Number of events 2 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
0.00%
0/38 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
5.3%
2/38 • Number of events 2 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
0.00%
0/38 • 3 months from radiotherapy.
The adverse events were reported according to the CTCAE 5.0 version.
|
Additional Information
Dr. SHI Changying
Shanghai Eastern Hepatobiliary Surgery Hospital
Phone: +86-021-81887735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place