Trial Outcomes & Findings for Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection (NCT NCT03575806)
NCT ID: NCT03575806
Last Updated: 2020-06-11
Results Overview
Recurrence-free survival was defined as the interval (in months) between hepatectomy and diagnosis of recurrence using either intrahepatic recurrence or extrahepatic metastasis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
12 months
Results posted on
2020-06-11
Participant Flow
This study was not of a randomized design, patients were recruited by their willingness to receive the Tcm transfusion as the adjuvant therapy after screening and meeting the eligibility criteria. As pathological classification with MVI was determined after 1 week postoperatively, patients consented with radical operation would be screened again.
Participant milestones
| Measure |
TACE Group
Control arm: only TACE
(TACE: transcatheter arterial chemoembolization)
|
TACE+Tcm Group
Experimental arm: TACE plus autologous Tcm immunotherapy
(TACE:transcatheter arterial chemoembolization)
Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
TACE Group
Control arm: only TACE
(TACE: transcatheter arterial chemoembolization)
|
TACE+Tcm Group
Experimental arm: TACE plus autologous Tcm immunotherapy
(TACE:transcatheter arterial chemoembolization)
Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TACE Group
n=25 Participants
Control arm: only TACE
(TACE: transcatheter arterial chemoembolization)
|
TACE+Tcm Group
n=23 Participants
Experimental arm: TACE plus autologous Tcm immunotherapy
(TACE:transcatheter arterial chemoembolization)
Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=25 Participants
|
17 Participants
n=23 Participants
|
41 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=25 Participants
|
6 Participants
n=23 Participants
|
7 Participants
n=48 Participants
|
|
Age, Continuous
|
53.4 years
n=25 Participants
|
53.7 years
n=23 Participants
|
53.5 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
7 Participants
n=23 Participants
|
13 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=25 Participants
|
16 Participants
n=23 Participants
|
35 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
25 participants
n=25 Participants
|
23 participants
n=23 Participants
|
48 participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group(ECOG)
ECOG=0
|
25 Participants
n=25 Participants
|
23 Participants
n=23 Participants
|
48 Participants
n=48 Participants
|
|
Eastern Cooperative Oncology Group(ECOG)
ECOG=1
|
0 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: PPS (Per Protocol Set)
Recurrence-free survival was defined as the interval (in months) between hepatectomy and diagnosis of recurrence using either intrahepatic recurrence or extrahepatic metastasis.
Outcome measures
| Measure |
TACE Group
n=25 Participants
Control arm: only TACE
(TACE: transcatheter arterial chemoembolization)
|
TACE+Tcm Group
n=23 Participants
Experimental arm: TACE plus autologous Tcm immunotherapy
(TACE:transcatheter arterial chemoembolization)
Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro.
|
|---|---|---|
|
Recurrence-free Survival (RFS) Time
|
9.5 months
Standard Deviation 3.99
|
12 months
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: 24 monthsOverall survival rate = the number of patients in TACE/TACE+Tcm group survived at 24 months/the number of total patients assigned into TACE/TACE+Tcm group.
Outcome measures
| Measure |
TACE Group
n=25 Participants
Control arm: only TACE
(TACE: transcatheter arterial chemoembolization)
|
TACE+Tcm Group
n=23 Participants
Experimental arm: TACE plus autologous Tcm immunotherapy
(TACE:transcatheter arterial chemoembolization)
Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro.
|
|---|---|---|
|
Overall Survival (OS) Rate at 24 Months
Survival
|
25 Participants
|
23 Participants
|
|
Overall Survival (OS) Rate at 24 Months
Death
|
0 Participants
|
0 Participants
|
Adverse Events
TACE Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
TACE+Tcm Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TACE Group
n=25 participants at risk
Control arm: only TACE
(TACE: TACE:transcatheter arterial chemoembolization)
|
TACE+Tcm Group
n=26 participants at risk
Experimental arm: TACE plus autologous Tcm immunotherapy
(TACE:transcatheter arterial chemoembolization)
Autologous Tcm immunotherapy: collected patient's own immune cells and then transfused back to patient after being amplified in vitro.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic pain
|
76.0%
19/25 • 12 months
Laboratory examination of blood tests, liver and kidney function of all patients were collected every 4 weeks during Tcm treatment and every 12 weeks after Tcm treatment in 48 weeks or ended the last follow-up. 1 patients assigned into TACE+Tcm group requested withdrawing without any administration of Tcm.
|
34.6%
9/26 • 12 months
Laboratory examination of blood tests, liver and kidney function of all patients were collected every 4 weeks during Tcm treatment and every 12 weeks after Tcm treatment in 48 weeks or ended the last follow-up. 1 patients assigned into TACE+Tcm group requested withdrawing without any administration of Tcm.
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
36.0%
9/25 • 12 months
Laboratory examination of blood tests, liver and kidney function of all patients were collected every 4 weeks during Tcm treatment and every 12 weeks after Tcm treatment in 48 weeks or ended the last follow-up. 1 patients assigned into TACE+Tcm group requested withdrawing without any administration of Tcm.
|
0.00%
0/26 • 12 months
Laboratory examination of blood tests, liver and kidney function of all patients were collected every 4 weeks during Tcm treatment and every 12 weeks after Tcm treatment in 48 weeks or ended the last follow-up. 1 patients assigned into TACE+Tcm group requested withdrawing without any administration of Tcm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place