Actively Recruiting
HAIC Combined With Camrelizumab Plus Rivoceranib for Advanced Mixed Hepatocellular-cholangiocarcinoma (HCC-CCA)
Led by Fudan University · Updated on 2025-08-17
45
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate HAIC combined with Camrelizumab plus rivoceranib for advanced mixed hepatocellular-cholangiocarcinoma (HCC-CCA).
CONDITIONS
Official Title
HAIC Combined With Camrelizumab Plus Rivoceranib for Advanced Mixed Hepatocellular-cholangiocarcinoma (HCC-CCA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained
- Age 18 years or older at study entry
- Disease not suitable for curative or local treatments
- Histologically confirmed mixed hepatocellular-cholangiocarcinoma
- No prior systemic therapy for hepatocellular carcinoma
- At least one measurable tumor site per RECIST1.1 criteria by CT or MRI
- Child-Pugh score between 5 and 7
- Performance status of 2 or less on the ECOG scale
- Chronic hepatitis B virus infection with viral load below 100 IU/mL and on antiviral therapy if applicable
- Life expectancy of at least 12 weeks
- Adequate blood counts, liver enzymes, and kidney function as specified
- Negative pregnancy test for females with reproductive potential within 7 days before starting trial
- Willingness and ability to follow study protocol including treatment and visits
You will not qualify if you...
- Listed for liver transplantation or have advanced liver disease
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks prior to treatment
- Thrombotic or embolic events within 6 months before first dose, except segmental portal vein thrombosis
- Prior systemic anti-cancer therapy, endocrine therapy, immunotherapy, or HAIC
- Presence of a second primary cancer except treated basal cell skin cancer or cervical carcinoma in situ
- Immunocompromised status including HIV infection
- Participation in another clinical study with investigational drug within last 30 days or 7 half-lives of prior medication
- Prior treatment in the current study
- Conditions interfering with study treatment or safety assessment, including lung disease, HBV/HCV coinfection, pancreatitis, active infections, organ transplant history, immunodeficiency, recent immunosuppressive therapy, active autoimmune disease requiring systemic treatment (with some exceptions), recent live vaccine, CNS metastases unless stable and asymptomatic
- Use of medications interfering with study drugs
- Any other effective cancer treatment at study start besides protocol treatment
- Receipt of investigational product within 28 days before study entry
- Prior therapy with specific immune checkpoint inhibitors or related drugs
- Pregnancy, breastfeeding, or not using effective birth control for patients of reproductive potential
- History of poor compliance with medical regimens or inability to give informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
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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