Status:
RECRUITING
Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Hepatocellular Carcinoma
Lead Sponsor:
Wei Zhang
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 Dep...
Eligibility Criteria
Inclusion
- 1\) Diagnosed with hepatocellular carcinoma by pathological or histological examination.
- 2\) the patient do not receive any anti-tumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy and targeted therapy
- 3)resectable centrally-located hepatocellular carcinoma in BCLC stage B; Surgical resection was feasible after MDT discussion.
- 4\) aged 18 to 70 years old, male or female
- 5\) at least one measurable lesions (according to RECISTv1.1 requirements, The long diameter of the measurable lesion in the spiral CT scan is ≥10 mm or The short diameter of the enlarged lymph nodes is ≥15 mm)
- 6\) ECOG score between 0 to 2, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤5 ULN, total serum bilirubin TBIL ≤1.5 ULN, creatinine (Cr)≤1.5ULN, HB≥80g/L, neutrophil \> 1.5×109/L ,Serum albumin \> 28 g/L
- 7\) Child - Pugh grade A or B (7 points or less); ICG - R15 \< 20%
- 8\) Sufficient future liver reserve (FLR): For patients with liver cirrhosis, FLR should be greater than 40% of the standard liver volume; for patients without liver cirrhosis, FLR should be greater than 30% of the standard liver volume.
- 9\) After assessment, TACE treatment can be deemed suitable.
- 10\) The subjects signed the informed consent form and voluntarily received the neoadjuvant treatment of Apatinib mesylate and Carlimzumab combined with TACE. They had good compliance and cooperated with the follow-up.
Exclusion
- 1\) Patients with intrahepatic cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
- 2\) Patients with a history of malignant tumors other than liver cancer.
- 3\) Patients with recurrent HCC after surgery who have received local or systemic treatment (chemotherapy, radiotherapy, surgery, interventional therapy, ablation, alcohol injection, or molecular targeted therapy).
- 4\) Patients who are currently receiving or have previously received organ transplantation or allogeneic bone marrow transplantation, or have immune deficiency diseases or a history of organ transplantation.
- 5\) Patients with vascular or biliary tumor thrombus or extrahepatic organ metastasis as shown by imaging.
- 6\) Patients with moderate to severe ascites requiring therapeutic puncture and drainage or uncontrolled pleural effusion or pericardial effusion.
- 7\) Patients with dysfunction of cardiovascular, respiratory, nervous, digestive, or urinary systems.
- 8\) Patients with a history of gastrointestinal bleeding within 6 months before the start of the study, with a tendency to gastrointestinal bleeding, abdominal fistula, gastrointestinal perforation, or abdominal abscess.
- 9\) Patients with multiple factors affecting oral drug administration (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption); patients allergic to the active ingredients or excipients of Camrelizumab and Apatinib mesylate.
- 10\) Pregnant or lactating women; patients with reproductive capacity who are unwilling or unable to take effective contraceptive measures.
- 11\) Patients with mental disorders or a history of abuse of psychotropic drugs.
- 12\) Patients who have experienced thrombosis or embolism events within 6 months before the start of the study, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
- 13\) Patients without legal capacity or with restricted legal capacity.
- 14\) Patients with any other conditions that the investigator deems unsuitable for participation in this trial.
Key Trial Info
Start Date :
December 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT07154082
Start Date
December 30 2025
End Date
July 31 2028
Last Update
September 4 2025
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030