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NCT04175912 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

A Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
40
Enrollment target
20
Study locations

NCT04175912: Active Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

NCT04175912 is a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 57-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04175912, a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.

Primary Outcome

Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Objective response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum

Conditions Studied

Stage III Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Metastatic Hepatocellular Carcinoma Stage IIIA Hepatocellular Carcinoma AJCC V8 Stage III Intrahepatic Cholangiocarcinoma AJCC v8 Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 Stage IIIB Hepatocellular Carcinoma AJCC V8 Metastatic Cholangiocarcinoma Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • DRUG Pevonedistat

Study Locations (20)

California

  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • PCR Oncology - Arroyo Grande
  • Sutter Auburn Faith Hospital - Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
  • Alta Bates Summit Medical Center-Herrick Campus - Berkeley
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
  • Eden Hospital Medical Center - Castro Valley
  • Sutter Davis Hospital - Davis

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Arizona

  • Kingman Regional Medical Center - Kingman
  • Cancer Center at Saint Joseph's - Phoenix

Arkansas

  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-03-16
Est. Completion 2026-10-31
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT04175912 still lists

NCT04175912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 57-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (30% lower).

The record links to 10 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.

NCT04175912 names 20 study sites across 4 states, led by California, Alaska, Arizona.

Frequently Asked Questions

What is clinical trial NCT04175912 about?

NCT04175912 is a clinical study titled "Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver". This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy...

What is the current status of trial NCT04175912?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-03-16. Estimated completion is 2026-10-31.

What conditions does trial NCT04175912 study?

This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Metastatic Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8.

What interventions are being tested in trial NCT04175912?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Pevonedistat (DRUG).

Who is sponsoring clinical trial NCT04175912?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04175912 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage III Hepatocellular Carcinoma AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04175912's enrollment target sits among peer trials

40 6th of 14 higher than 9 of 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage III Hepatocellular Carcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04175912, the US trial registry maintained by the National Library of Medicine. NCT04175912 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.