Actively Recruiting
Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC
Led by National Cancer Centre, Singapore · Updated on 2025-09-23
60
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm phase II study of adjuvant intra-dermal NA DC vaccine combined with intravenous nivolumab in patients with resectable HCC (group A) or CRLM (group B) planned for curative surgery (with/without local ablation).
CONDITIONS
Official Title
Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with newly diagnosed or recurrent hepatocellular carcinoma (HCC) suitable for surgery with or without local ablation, meeting specific tumor size and number criteria
- Participants with colorectal cancer with liver-only metastases planned for curative surgery, with or without local ablation
- Primary colorectal tumor resected or planned for surgical removal
- Received or planned for peri-operative or adjuvant chemotherapy
- Age 21 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate blood counts and organ function within 28 days prior to enrollment
- Women of childbearing potential must have a negative pregnancy test and agree to contraception during and 7 months after treatment
- Men sexually active with women of childbearing potential must agree to contraception during and 7 months after treatment
- Participants with non-viral, hepatitis B, or hepatitis C related HCC meeting specific viral status and treatment criteria
You will not qualify if you...
- Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Evidence of tumor spread outside the liver or co-existing cancer
- Macrovascular invasion seen on imaging
- Prior liver transplant or waiting for transplant
- Previous systemic therapy, trans-arterial embolization, chemoembolization, selective internal radiation therapy, or stereotactic radiation for HCC
- Extra-hepatic colorectal metastases
- Active co-infection with both hepatitis B and C or hepatitis D with hepatitis B
- HIV infection or AIDS
- Serious uncontrolled medical conditions increasing study risk or interfering with treatment
- Active autoimmune disease requiring systemic treatment
- Use of corticosteroids over 10 mg prednisone equivalent or other immunosuppressants within 14 days before treatment
- Prior malignancy active within the past 3 years except certain cured cancers
- Prior treatment with checkpoint inhibitors or T-cell targeting antibodies
- Use of herbal or traditional medicines within 2 weeks before treatment
- Positive pregnancy test
- History of severe allergy to monoclonal antibodies or study drug components
- Prisoners or involuntarily incarcerated individuals
- Participants compulsorily detained for psychiatric or physical illnesses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center Singapore
Singapore, Singapore, 169690
Actively Recruiting
Research Team
S
Si Lin Koo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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