Apatinib and camrelizumab plus TACE before liver resection for centrally-located BCLC‑B hepatocellular carcinoma

A Prospective, Single-arm, Phase Ⅱ Study of Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Resectable Centrally-located Hepatocellular Carcinoma in BCLC Stage B

This trial tests whether giving apatinib and camrelizumab together with TACE before planned liver surgery can shrink tumors and improve outcomes for adults with centrally-located BCLC stage B hepatocellular carcinoma who are eligible for resection.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: Carlimzumab, Camrelizumab, Apatinib, chemotherapy, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07154082 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm Phase II trial conducted at Tongji Hospital that gives neoadjuvant therapy combining transarterial chemoembolization (TACE) with the oral VEGFR2 inhibitor apatinib and the PD‑1 antibody camrelizumab before planned liver resection. Eligible patients are adults (18–70) with centrally-located, resectable BCLC stage B HCC who have not received prior anti-tumor treatment and have adequate organ and liver function. The study aims to downstage tumors, increase the rate of complete (R0) resections and reduce early recurrence while monitoring safety and tolerability. Outcomes will include tumor response, resection margin status, recurrence and survival measures as well as treatment-related adverse events.

Who should consider this trial

Good fit: Adults aged 18–70 with centrally-located, resectable BCLC stage B hepatocellular carcinoma, no prior anti-cancer treatment, at least one measurable lesion, ECOG 0–2, adequate organ and liver function, and sufficient future liver remnant are ideal candidates.

Not a fit: Patients with unresectable disease, prior anti-tumor therapy, poor liver function (Child‑Pugh > B or ICG‑R15 ≥20%), inadequate organ function, or inability to undergo surgery are unlikely to benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, the approach could increase the chance of complete (R0) resection, lower early recurrence risk, and potentially extend survival for selected patients.

How similar studies have performed: Prior studies combining locoregional therapy with targeted agents or PD‑1 inhibitors have shown promising downstaging and response signals, but neoadjuvant combinations like apatinib plus camrelizumab with TACE remain investigational and not yet definitively proven.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: WeiZhang, MD

Conditions Hepatocellular Carcinoma; TACE; Hepatocellular carcinoma; Camrelizumab; apatinib; neoadjuvant therapy