Actively Recruiting
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Led by TaiRx, Inc. · Updated on 2026-04-13
95
Participants Needed
5
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.
CONDITIONS
Official Title
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (20+ for subjects in Taiwan)
- Diagnosis of hepatocellular carcinoma confirmed by pathology, cytology, or clinical criteria per AASLD
- Advanced-stage, unresectable hepatocellular carcinoma not suitable for curative therapy
- Progressed on or intolerant to prior systemic anti-cancer therapies such as sorafenib, lenvatinib, or atezolizumab with bevacizumab
- BCLC stage B not suitable for or progressed after local regional therapy, or BCLC stage C
- Child-Pugh liver function class A
- Measurable disease according to mRECIST criteria
- ECOG performance status of 0 or 1
- Adequate laboratory values including AST/ALT ≤3.0x ULN (≤5.0x ULN if liver involvement), total bilirubin ≤2.0x ULN (≤3.0x ULN if Gilbert's syndrome), ANC ≥1500/µL, platelets ≥90,000/µL, hemoglobin ≥9.0 g/dL, creatinine clearance ≥50 mL/min, serum albumin ≥2.8 g/dL, INR ≤2.3, PT/aPTT ≤1.2x ULN
- QTcF ≤480 msec
- For HBV-HCC: chronic HBV infection with HBV DNA <500 IU/mL on antiviral therapy or willing to start therapy
- For HCV-HCC: active or resolved HCV infection confirmed by RNA or antibody testing
You will not qualify if you...
- Hepatocellular carcinoma with portal vein invasion at main portal branch (Vp4)
- History of esophageal varices or gastrointestinal bleeding within 3 months
- Prior immunotherapy for hepatocellular carcinoma
- Less than 7 days since prior limited field palliative radiation therapy
- Less than 28 days since prior radiation therapy
- Less than 14 days (or 5 half-lives) since prior systemic anticancer therapy
- Less than 28 days since prior local regional therapy such as embolization or ablation
- Presence of other active cancers requiring treatment in next 2 years or impacting study assessments
- Active bacterial or fungal infections requiring systemic therapy within 7 days before treatment
- Known brain metastases
- Known HIV infection
- Currently pregnant or breastfeeding females
- Known gastrointestinal diseases affecting oral drug absorption
- Psychiatric or social conditions interfering with study compliance
- History of clinically significant heart abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
2
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
Actively Recruiting
3
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
4
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
Research Team
Y
Yen-Ling Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here