Trial Outcomes & Findings for Study of Pembrolizumab Following TACE in Primary Liver Carcinoma (NCT NCT03397654)
NCT ID: NCT03397654
Last Updated: 2025-03-06
Results Overview
The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 years
Results posted on
2025-03-06
Participant Flow
Participant milestones
| Measure |
TACE Followed by Pembrolizumab
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab: Pembrolizumab solution
Trans-arterial chemoembolization: Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TACE Followed by Pembrolizumab
n=15 Participants
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab: Pembrolizumab solution
Trans-arterial chemoembolization: Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=15 Participants
|
|
Age, Continuous
|
72 Years
n=15 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=15 Participants
|
|
Eastern Cooperative Oncology Group performance
ECOG 0
|
9 Participants
n=15 Participants
|
|
Eastern Cooperative Oncology Group performance
ECOG 1
|
6 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 yearsPopulation: Patients with liver confirmed Hepatocellular carcinoma
The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4).
Outcome measures
| Measure |
TACE Followed by Pembrolizumab
n=15 Participants
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab: Pembrolizumab solution
Trans-arterial chemoembolization: Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
|
|---|---|
|
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability)
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with liver confirmed Hepatocellular carcinoma
PFS was defined by the time from last TACE to the first occurrence of documented disease progression based on RECIST v1.1 criteria or death from any cause, whichever occurred first, and it was calculated using Kaplan-Meier.
Outcome measures
| Measure |
TACE Followed by Pembrolizumab
n=15 Participants
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab: Pembrolizumab solution
Trans-arterial chemoembolization: Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
|
|---|---|
|
Progression-free Survival Rate (PFS; Efficacy) at 12 Weeks
|
93.3 Percentage
Interval 82.0 to 100.0
|
Adverse Events
TACE Followed by Pembrolizumab
Serious events: 7 serious events
Other events: 14 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
TACE Followed by Pembrolizumab
n=15 participants at risk
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab: Pembrolizumab solution
Trans-arterial chemoembolization: Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
|
|---|---|
|
General disorders
Fatigue
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
General disorders
Anorexia
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
General disorders
Flu-like symptoms
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Bilirubin increase
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
Other adverse events
| Measure |
TACE Followed by Pembrolizumab
n=15 participants at risk
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab: Pembrolizumab solution
Trans-arterial chemoembolization: Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
|
|---|---|
|
General disorders
Fatigue
|
66.7%
10/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
General disorders
Anorexia
|
66.7%
10/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
60.0%
9/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Diarrhoea
|
53.3%
8/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
6/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
6/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
5/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
General disorders
Lethargy
|
33.3%
5/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
5/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
5/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Skin and subcutaneous tissue disorders
Peripheral oedema
|
33.3%
5/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral neuropathy
|
33.3%
5/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
4/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
General disorders
Flu-like symptoms
|
26.7%
4/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
4/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Bilirubin increase
|
20.0%
3/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Mucositis
|
20.0%
3/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Dysgeusia
|
20.0%
3/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Gastrointestinal disorders
Hypothyroidism
|
20.0%
3/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
3/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
3/15 • Through study completion , an average of 1.5 years.
CTCAE version v5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place