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NCT05775159 · ClinicalTrials.gov registry record · Phase 2
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
A Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 294
- Enrollment target
- 20
- Study locations
NCT05775159: Recruiting Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer, sponsored by AstraZeneca.
NCT05775159 is a Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 294 participants, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05775159, a Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 294 participants
- Enrollment target
- 20
- Study locations
Study Summary
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
Primary Outcome
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Gemcitabine
- DRUG Rilvegostomig
- DRUG Lenvatinib
- DRUG Volrustomig
Study Locations (20)
Other
- Research Site - Beijing
- Research Site - Beijing
- Research Site - Beijing
- Research Site - Chengdu
- Research Site - Chengdu
- Research Site - Chongqing
- Research Site - Fuzhou
- Research Site - Guangzhou
- Research Site - Guangzhou
- Research Site - Harbin
California
- Research Site - Costa Mesa
- Research Site - Los Angeles
- Research Site - Orange
Alabama
- Research Site - Birmingham
Florida
- Research Site - Miami Beach
Indiana
- Research Site - Dyer
Kansas
- Research Site - Kansas City
New York
- Research Site - New York
Texas
- Research Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2027-10-28 |
| Phase | Phase 2 |
What NCT05775159 shows while recruiting
NCT05775159 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (15% higher).
The record links to 2 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT05775159 names 20 study sites across 9 states, led by Other, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05775159 about?
NCT05775159 is a clinical study titled "Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer". GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
What is the current status of trial NCT05775159?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 294 participants. The study started on 2023-04-24. Estimated completion is 2027-10-28.
What conditions does trial NCT05775159 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Biliary Tract Cancer.
What interventions are being tested in trial NCT05775159?
The interventions under investigation include: Bevacizumab (DRUG), Gemcitabine (DRUG), Rilvegostomig (DRUG), Lenvatinib (DRUG), Volrustomig (DRUG).
Who is sponsoring clinical trial NCT05775159?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05775159 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05775159's enrollment target sits among peer trials
294 38th of 145 higher than 108 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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.
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