OncoMatch/Clinical Trials/NCT04134559
Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma
Is NCT04134559 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for hepatocellular carcinoma, childhood.
Treatment: Pembrolizumab — This research study is studying an immunotherapy drug (pembrolizumab or KEYTRUDA) as a possible treatment for pediatric hepatocellular carcinoma or hepatocellular neoplasm not otherwise specified (HCN NOS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Prior therapy
Cannot have received: checkpoint inhibitor
Participants who have received checkpoint inhibitors (PD-1, PD-L1, and CTLA-4 inhibitors) are not eligible.
Cannot have received: antibody-based therapy
Exception: allowed if >3 half-lives since last antibody dose
Participants who have received antibody-based therapies are not eligible if they are within 3 half-lives of receipt of the last antibody dose.
Cannot have received: chronic steroids
Participants who are receiving chronic steroids are not eligible. Chronic steroids are defined as either >= 2mg/kg/day of body weight or >= 20mg/day of prednisone or equivalent for persons who weigh >= 10kg administered for >= 14 consecutive days.
Cannot have received: anti-inflammatory or immunosuppressive medications
Participants who are receiving anti-inflammatory or immunosuppressive medications are not eligible.
Cannot have received: investigational agents
Participants who are receiving any other investigational agents are not eligible.
Lab requirements
Blood counts
Peripheral ANC ≥ 750/μL; Platelet count ≥ 75,000/μL (can be transfused)
Kidney function
Serum creatinine below age/gender thresholds OR creatinine clearance ≥60 mL/min/1.73 m2 for elevated creatinine; Amylase ≤ 1.5 x ULN; Lipase ≤ 1.5 x ULN
Liver function
Total bilirubin < 1.5 x institutional ULN; AST(SGOT) ≤ 2.5 x ULN; ALT(SGPT) ≤ 2.5 x ULN; if elevated due to tumor, eligibility after PI discussion.
Organ Function Requirements: Participants must have normal organ and marrow function as defined below: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco · San Francisco, California
- Children's Hospital Boston · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
- Cincinnati Children's Medical Center · Cincinnati, Ohio
- Baylor College of Medicine · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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