Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Patients who fulfill eligibility criteria will be entered into the trial to receive pembrolizumab or KEYTRUDA This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. In the case of this trial, the investigators are studying whether pembrolizumab can treat pediatric hepatocellular carcinoma. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for your specific disease but it has been approved for other uses in adults. Checkpoint inhibitors are in early-phase study in pediatric patients across diagnoses. In this research study, the investigators plan to investigate whether pediatric patients with hepatocellular carcinoma experience stable disease or response to pembrolizumab. In addition, the investigators would like to explore different biological factors of the tumor and immune system that might help us predict whether pediatric patients with HCC may benefit from treatment with pembrolizumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04134559
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	DFCI Clinical Trials Hotline
Phone	877-DF-TRIAL
Email	allison_oneill@dfci.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	November 1, 2020
Completion date	January 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03213314` - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies	N/A
Not yet recruiting	`NCT04931420` - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	Phase 2
Terminated	`NCT00788125` - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors	Phase 1/Phase 2
Completed	`NCT03756597` - PAN-study: Pan-Cancer Early Detection Study (PAN)
Recruiting	`NCT05160740` - Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	N/A
Completed	`NCT01906021` - Study of New Software Used During Ablations	N/A
Terminated	`NCT04589884` - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Recruiting	`NCT05953337` - Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)	N/A
Enrolling by invitation	`NCT04466124` - Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
Not yet recruiting	`NCT04053231` - Hepatocarcinoma Recurrence on the Liver Study - Part2
Active, not recruiting	`NCT02869217` - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors	Phase 1
Completed	`NCT03059238` - Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure	Phase 3
Recruiting	`NCT02632188` - Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma	Phase 1/Phase 2
Recruiting	`NCT01388101` - Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)	N/A
Completed	`NCT01042041` - Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer	Phase 1
Completed	`NCT00980239` - HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver	Phase 1
Terminated	`NCT00903396` - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer	Phase 2
Completed	`NCT00790569` - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking	N/A
Terminated	`NCT00896467` - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy	N/A
Completed	`NCT00543777` - Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease	Phase 1/Phase 2