Actively Recruiting
the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma
Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2023-03-10
576
Participants Needed
5
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .
CONDITIONS
Official Title
the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Diagnosed with unresectable advanced hepatocellular carcinoma (HCC) confirmed by biopsy or cytology, Stage B or C by BCLC, not eligible for or progressed after surgery or local therapy
- No prior systemic therapy for HCC, including chemotherapy, anti-angiogenic drugs, molecular targeted therapy, or immunotherapy
- At least one measurable tumor lesion by RECIST1.1, with baseline imaging within 21 days before first treatment
- Child-Pugh liver function class A or B (score 4) with no history of hepatic encephalopathy
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate vital organ function including blood counts, liver, kidney, coagulation, and protein levels within specified limits
- If hepatitis B virus positive, HBV DNA less than 2000 IU/mL and willing to receive anti-HBV therapy during study
- Able and willing to provide written informed consent and comply with study protocol
You will not qualify if you...
- Fibrolamellar HCC, sarcomatoid, cholangiocellular carcinoma or mixed tumors
- History of other cancers within past 5 years except certain locally curable cancers
- Recent palliative radiotherapy for bone metastases or recent anti-liver cancer drugs
- Uncontrolled fluid build-up such as pericardial or pleural effusion
- Serious wounds, active ulcers, or untreated bone fractures
- Recent or high risk of gastrointestinal bleeding
- Difficulty swallowing tablets or malabsorption conditions
- Severe gastrointestinal or other fistulas
- Extensive portal vein or inferior vena cava tumor thrombus
- Serious heart or brain vascular diseases, including recent heart failure, angina, heart attack, stroke, or uncontrolled hypertension
- Significant bleeding disorders or recent thrombotic events
- Recent major surgery (within 4 weeks) except biopsy
- Central nervous system metastases
- Recent live vaccinations or planned live vaccinations during study
- Immunodeficiency or recent long-term steroid or immunosuppressive therapy
- Active autoimmune diseases requiring systemic treatment
- History of interstitial lung disease or non-infectious pneumonia (unless radiation-induced)
- Active or recent tuberculosis
- Serious infections requiring systemic treatment
- HIV infection or certain viral hepatitis infections
- Previous solid organ transplantation
- Known allergies to study drugs or ingredients
- Pregnant or breastfeeding women; those unwilling to use contraception during and 6 months after study
- Any other condition the investigator judges unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
Huizhou Central People's Hospital
Guandong, China
Actively Recruiting
3
Jinan Central Hospital
Shandong, China
Actively Recruiting
4
Linyi Cancer Hospital
Shandong, China
Actively Recruiting
5
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, China
Actively Recruiting
Research Team
Z
Zhou Ai ping, professor
CONTACT
C
Cai Jian qiang, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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