Actively Recruiting
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
Led by Pfizer · Updated on 2026-04-20
138
Participants Needed
11
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced or metastatic HCC. * Is not a candidate for complete surgical or loco-regional therapies. * Have not received any whole-body treatment for HCC. Participants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
CONDITIONS
Official Title
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at screening.
- Locally advanced or metastatic hepatocellular carcinoma (HCC) confirmed by biopsy or clinical criteria.
- Disease not suitable for curative surgery or local therapies, or progressive disease after such treatments.
- At least one measurable and untreated tumor lesion.
- Adequate liver, hepatic, and kidney function.
- No prior whole-body treatment for HCC.
- ECOG performance status of 0 or 1.
- Child-Pugh Class A liver function.
You will not qualify if you...
- Moderate or severe ascites.
- History of hepatic encephalopathy.
- Active central nervous system lesions including metastases or compression.
- Significant risk of bleeding or fistula.
- History of another cancer within the last 3 years.
- History of organ or stem cell transplantation.
- Active autoimmune diseases needing systemic treatment within past 2 years.
- Significant cardiovascular disease within 6 months before first dose.
- Major surgery or severe trauma within 4 weeks before first dose or planned during study.
- History of severe bleeding disorders.
- Recent severe ulcers, unhealed wounds, gastrointestinal issues, or bleeding within 6 months before first dose.
- Current acute, chronic, or symptomatic infections.
- History of immune deficiency.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Renown Health Medical Oncology
Reno, Nevada, United States, 89502
Actively Recruiting
2
Renown Office of Clinical Research
Reno, Nevada, United States, 89502
Actively Recruiting
3
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
4
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Not Yet Recruiting
5
Kindai University Hospital- Osaka Medical Campus
Sakai, Osaka, Japan, 590-0197
Actively Recruiting
6
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
7
Pan American Center for Oncology Trials, LLC - Dorado Office
Dorado, United States of America, Puerto Rico, 00646
Actively Recruiting
8
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, United States of America, Puerto Rico, 00680
Actively Recruiting
9
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
10
Pan American Center for Oncology Trials, LLC
San Juan, Puerto Rico, 00909
Actively Recruiting
11
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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