Actively Recruiting
A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2026-01-21
72
Participants Needed
2
Research Sites
1001 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study that aimed to assess the safety and anti-tumor activity of CCAR031 injection in unresectable HCC patients.
CONDITIONS
Official Title
A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with ability to sign informed consent
- Age between 18 and 75 years at screening
- Histologically confirmed hepatocellular carcinoma (HCC) with Barcelona Clinic Liver Cancer Stage B or C
- Child-Pugh score of 6 or less
- Possible expression of GPC3 in tumor tissues
- Relapsed or progressive disease after at least one prior standard systemic therapy for HCC, or ineligible or unable to tolerate such therapies
- For C-CAR031 plus Lenvatinib group: no prior Lenvatinib therapy and progression or intolerance to prior systemic therapy including immune checkpoint inhibitors and VEGF/VEGFR-targeted agents
- For C-CAR031 plus Regorafenib group: no prior Regorafenib therapy and progression or intolerance to prior systemic therapy including immune checkpoint inhibitors and VEGF/VEGFR-targeted agents
- For C-CAR031 plus Durvalumab group: progression or intolerance to prior systemic therapy including immune checkpoint inhibitors and VEGF/VEGFR-targeted agents; no prior immune-related toxicity causing permanent immunotherapy discontinuation; no history of grade 3 or higher immune-related adverse events or neurological/ocular immune-related adverse events; stable endocrine adverse events if present
- At least one measurable target lesion per RECIST v1.1
- WHO/ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Left ventricular ejection fraction of 45% or higher by echocardiography
- No active pulmonary infection or history of pneumonitis requiring steroids
- Laboratory requirements including sufficient neutrophils, lymphocytes, platelets, hemoglobin, liver and kidney function within specified limits
- No active HBV infection or controlled HBV with antiviral therapy
- Negative pregnancy test for females of child-bearing age and agreement to use contraception
- Agreement to abstain from alcohol during the study
You will not qualify if you...
- History of severe allergy or hypersensitivity to DMSO or components of Lenvatinib, Regorafenib, or Durvalumab
- History of liver transplantation
- History of prior cell therapy
- Tumor volume greater than 50% of the liver
- Portal stem vein tumor thrombus
- Moderate to severe ascites
- Bone or central nervous system metastases or CNS diseases
- Radiotherapy within 6 weeks prior to apheresis
- Local therapy within 4 weeks prior to apheresis or unhealed wounds
- Recent systemic treatments not meeting washout periods or unresolved toxicities
- History of other primary cancers except certain cured skin or in situ carcinomas
- Active hepatitis C virus infection
- Syphilis infection
- History of active or immunodeficient diseases excluding certain stable or minor conditions
- Persistent active infections
- Uncontrolled hypertension, diabetes, arrhythmia, or symptomatic heart failure
- Dementia or significant mental state changes
- Severe cardiac insufficiency or unstable heart/lung diseases
- Significant bleeding risks
- Pregnancy or breastfeeding females
- Other diseases increasing risk or interfering with the study
- For combination groups: history of renal disease, severe gastrointestinal disorders, significant bleeding, recent thromboembolic events, serious wounds, use of certain anticoagulants, recent thromboembolism, or uncontrolled hypertension
- Severe chronic gastrointestinal disorders associated with diarrhea (excluded from durvalumab group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
2
The first affiliated hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
Q
Qihan Fu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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