Actively Recruiting
Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Hepatocellular Carcinoma
Led by Wei Zhang · Updated on 2025-09-04
27
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single-arm, phase Ⅱtrial. The subjects are patients resectable centrally-located hepatocellular carcinoma in BCLC stage B who are admitted to the Hepatobiliary Surgery Department of Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology, are over 18 years old, and have signed the informed consent form to voluntarily participate in this study. Through the neoadjuvant treatment of Apatinib mesylate and Camrelizumab combined with TACE before liver resection, it is expected to reduce the tumor size, lower the tumor burden, increase the surgical margin, improve the R0 resection rate, decrease the postoperative recurrence risk, and prolong the overall survival.
CONDITIONS
Official Title
Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma by pathological or histological examination.
- No prior anti-tumor treatment including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
- Resectable centrally-located hepatocellular carcinoma in BCLC stage B, with surgical resection deemed feasible after multidisciplinary discussion.
- Aged 18 to 70 years, male or female.
- At least one measurable lesion meeting RECIST v1.1 criteria: lesion long diameter 610 mm or enlarged lymph nodes short diameter 615 mm.
- ECOG score between 0 to 2; liver and kidney function within specified limits (ALT and AST 65 ULN, TBIL 61.5 ULN, creatinine 61.5 ULN); hemoglobin 80 g/L; neutrophil count > 1.5 x10^9/L; serum albumin > 28 g/L.
- Child-Pugh grade A or B (7 points or less); ICG-R15 < 20%.
- Sufficient future liver reserve: > 40% standard liver volume if cirrhosis present; > 30% if not.
- Suitable for TACE treatment after assessment.
- Signed informed consent and willing to comply with treatment and follow-up.
You will not qualify if you...
- Diagnosis of intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
- History of malignant tumors other than liver cancer.
- Recurrent HCC after surgery with prior local or systemic treatment.
- Current or prior organ transplantation or allogeneic bone marrow transplantation, or immune deficiency diseases.
- Presence of vascular or biliary tumor thrombus or extrahepatic metastasis.
- Moderate to severe ascites requiring drainage, or uncontrolled pleural or pericardial effusion.
- Dysfunction of cardiovascular, respiratory, nervous, digestive, or urinary systems.
- History of gastrointestinal bleeding within 6 months, tendency to bleeding, abdominal fistula, perforation, or abscess.
- Conditions affecting oral drug administration or allergies to study drugs.
- Pregnant or lactating women, or those unwilling/unable to use contraception.
- Mental disorders or history of psychotropic drug abuse.
- Thrombosis or embolism events within 6 months.
- Lack of legal capacity or restricted legal capacity.
- Any other conditions deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
W
WeiZhang, 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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