Actively Recruiting
Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC
Led by Lei ZHAO · Updated on 2025-04-01
40
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, randomized controlled exploratory Phase II clinical trial, aiming to assess the efficacy and safety of sintilimab combined with lenvatinib and HAIC for two cycles followed by surgery compared with direct surgery in patients with borderline resectable hepatocellular carcinoma. After signing the informed consent and meeting the inclusion and exclusion criteria, the eligible subjects were randomly divided into the experimental group and the control group: * Subjects in the experimental group received 200 mg of sintilimab by intravenous infusion on the first day of every 3 weeks. Lenvatinib 8 mg was orally administered once daily, combined with the HAIC-FOLFOX regimen. After two cycles, the patients' conditions were evaluated for surgery. * Subjects in the control group underwent surgery directly. Both groups of subjects received sintilimab monotherapy as adjuvant treatment for half a year (a total of 8 cycles) after surgery. The treatment was terminated if there was disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or other reasons stipulated in the protocol.
CONDITIONS
Official Title
Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Male or female aged 18 to 70 years
- ECOG performance status score of 0 to 2
- Diagnosed with hepatocellular carcinoma (HCC) according to Chinese guidelines
- CNLC stage IIIa with vascular invasion but no spread outside the liver
- Child-Pugh liver function score of A or B
- Portal vein tumor thrombus classified as type 1-2 (Japanese) or type I-II (Program classification)
- No previous systemic anti-tumor treatment for HCC and eligible for complete tumor removal (R0 resection)
- Expected survival time greater than 3 months
- At least one measurable tumor lesion by RECIST 1.1 or mRECIST criteria
- Adequate blood, liver, kidney, and coagulation function within specified laboratory limits
- Continuous antiviral treatment for hepatitis B or C if applicable
- Negative pregnancy test for females of childbearing age before first treatment
- Use of effective contraception during treatment and for 120 days after last dose
- Expected survival time of at least 12 weeks
You will not qualify if you...
- Diagnosis of liver cancer types such as fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma
- History of hepatic encephalopathy or liver transplantation
- Symptoms requiring drainage of pleural, abdominal, or pericardial fluid
- Active hepatitis B or C infection with high viral loads
- Presence of cancer spread to the central nervous system
- Recent serious esophageal or gastric bleeding or high-risk portal hypertension
- Life-threatening bleeding events within the past 3 months
- Venous or arterial blood clots within the past 6 months, except stable thrombosis after treatment
- Recent use of high-dose aspirin or other platelet inhibitors
- Uncontrolled high blood pressure or history of hypertensive emergencies
- Symptomatic or poorly controlled heart failure or arrhythmia
- Severe bleeding disorders or ongoing clot-dissolving therapy
- Recent gastrointestinal perforation, fistula, obstruction, or chronic inflammatory bowel disease
- Radiotherapy within 3 weeks before treatment unless no toxicity and no steroid use
- History of severe lung diseases or impaired lung function
- HIV or known syphilis infection
- Active severe infection or recent hospitalization for infection
- Active autoimmune disease requiring systemic treatment within 2 years
- Recent use of immunosuppressive drugs beyond allowed exceptions
- Receipt of live vaccines within 4 weeks before treatment or planned during study
- Recent local liver cancer treatments or traditional Chinese medicine with anti-tumor effects
- Uncontrolled metabolic or systemic diseases increasing medical risks
- Other cancers diagnosed within 5 years except certain skin cancers
- Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-CTLA4, or similar agents
- Known allergy to study drugs or severe allergic reactions to similar treatments
- Participation in other clinical trials within 4 weeks before treatment
- Pregnant or breastfeeding women
- Other medical or psychiatric conditions increasing risks or affecting study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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