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Study of Pembrolizumab and Radiotherapy in Liver Cancer
Phase 2 trial testing Pembrolizumab in Hepatocellular Carcinoma in 18 participants. Terminated before completion.
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 15 February 2018 |
| Primary completion | 15 February 2024 |
| Estimated completion | 15 February 2024 |
| Sites | 1 location across Canada |
University Health Network, Toronto
18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To assess the systemic efficacy of combined SBRT and pembrolizumab in subjects with advanced HCC who have experienced disease progression after previous therapy, as measured by overall response rate (ORR).
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) | 41 | 18 – 67 |
To determine the progression-free survival (PFS), in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) | 0.45 | 0.233 – 0.825 |
To determine the overall survival (OS) in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) | 1.05 | 0.475 – 2.15 |
Time frame: 3 years, up to 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pembrolizumab and Stereota… |
|---|---|---|
| Ascites grade 3 | Gastrointestinal disorders | — |
| Blood bilirubin increased grade 2 | Investigations | — |
| Aspartate aminotransferase increased grade 3 | Investigations | — |
| Pneumonitis grade 3 | Respiratory, thoracic and mediastinal disorders | — |
| Alanine aminotransferase increased grade 3 | Investigations | — |
| Bone infection grade 3 | Infections and infestations | — |
| Blood bilirubin increased grade 1 | Investigations | — |
| Blood bilirubin increased grade 3 | Investigations | — |
| Acute kidney injury grade 3 | Renal and urinary disorders | — |
| Tumor lysis syndrome grade 3 | Metabolism and nutrition disorders | — |
| Febrile neutropenia grade 3 | Blood and lymphatic system disorders | — |
| RASH grade 2 | Skin and subcutaneous tissue disorders | — |
| Generalized muscle weakness grade 2 | Musculoskeletal and connective tissue disorders | — |
| Atrial fibrillation grade 1 | Cardiac disorders | — |
| Hepatic failure grade 4 | Hepatobiliary disorders | — |
| Hepatic failure grade 5 | Hepatobiliary disorders | — |
| Myocarditis grade 4 | Cardiac disorders | — |
| Myocarditis grade 5 | Cardiac disorders | — |
| MOUTH SORES grade 2 | General disorders | — |
| Fever grade 1 | General disorders | — |
| Acidosis grade 4 | Metabolism and nutrition disorders | — |
| Hyperglycemia grade 2 | Metabolism and nutrition disorders | — |
| Vomiting grade 2 | Gastrointestinal disorders | — |
| Dyspnea grade 2 | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea grade 3 | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Pembrolizumab and Stereota… |
|---|---|---|
| Aspartate aminotransferase increased grade 1 | Investigations | — |
| Alkaline phosphatase increased grade 1 | Investigations | — |
| Platelet count decreased grade 1 | Investigations | — |
| Alanine aminotransferase increased grade 1 | Investigations | — |
| Fatigue grade 1 | General disorders | — |
| Fatigue grade 2 | General disorders | — |
| Abdominal pain grade 1 | Gastrointestinal disorders | — |
| Lymphocyte count decreased grade 2 | Investigations | — |
| Lymphocyte count decreased grade 3 | Investigations | — |
| Anemia grade 1 | Blood and lymphatic system disorders | — |
| Diarrhea grade 1 | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased grade 2 | Investigations | — |
| Blood bilirubin increased grade 1 | Investigations | — |
| Hypocalcemia grade 1 | Metabolism and nutrition disorders | — |
| Hypoalbuminemia grade 1 | Investigations | — |
| Constipation grade 1 | Gastrointestinal disorders | — |
| Blood bilirubin increased grade 2 | Investigations | — |
| Platelet count decreased grade 2 | Investigations | — |
| Lymphocyte count decreased grade 1 | Investigations | — |
| Hypomagnesemia grade 1 | Metabolism and nutrition disorders | — |
| Pruritus grade 1 | Skin and subcutaneous tissue disorders | — |
| Dyspnea grade 2 | Respiratory, thoracic and mediastinal disorders | — |
| Nausea grade 1 | Gastrointestinal disorders | — |
| Anorexia grade 1 | Metabolism and nutrition disorders | — |
| Anorexia grade 2 | Metabolism and nutrition disorders | — |
| Alanine aminotransferase increased grade 2 | Investigations | — |
| Hyponatremia grade 1 | Metabolism and nutrition disorders | — |
| Ascites grade 2 | Gastrointestinal disorders | — |
| Abdominal pain grade 2 | Gastrointestinal disorders | — |
| INR increased grade 1 | Investigations | — |
| White blood cell decreased grade 1 | Investigations | — |
| Cough grade 1 | Respiratory, thoracic and mediastinal disorders | — |
| Anemia grade 2 | Blood and lymphatic system disorders | — |
| Nausea grade 2 | Gastrointestinal disorders | — |
| Hyponatremia grade 3 | Metabolism and nutrition disorders | — |
| Edema limbs grade 1 | General disorders | — |
| Hypocalcemia grade 2 | Metabolism and nutrition disorders | — |
| Neutrophil count decreased grade 2 | Investigations | — |
| Hypoalbuminemia grade 2 | Investigations | — |
| Anemia grade 3 | Blood and lymphatic system disorders | — |
Most-reported serious reactions: Ascites grade 3, Blood bilirubin increased grade 2, Aspartate aminotransferase increased grade 3, Pneumonitis grade 3, Alanine aminotransferase increased grade 3, Bone infection grade 3, Blood bilirubin increased grade 1, Blood bilirubin increased grade 3.
Data from ClinicalTrials.gov NCT03316872 adverse events section.
This is a phase 2 study whose purpose is to assess the efficacy of the combination of pembrolizumab and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after treatment with sorafenib.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03316872.
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