Not yet recruiting NCT07684040

A Study of Combination Therapy in Patients With Resectable Liver Cancer

Phase II Interventional Liver Cancer (Primary and Metastatic)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib.
Who it may be relevant to: Registry conditions: Liver Cancer (Primary and Metastatic). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective Single-arm Clinical Study Evaluating the Efficacy and Safety of Hepatic Resection After Initial Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab Plus Rivoceranib in Patients With Initially Resectable Hepatocellular Carcinoma

Overview

This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of an initial combination treatment strategy followed by surgery in patients with cancer. Eligible participants will receive combination therapy prior to surgical intervention. Patients who meet predefined surgical criteria will undergo hepatic resection. Following surgery, additional treatment may be administered according to the investigator's assessment. The primary objective is to evaluate time to treatment failure (TTF). Secondary objectives include evaluation of pathological response, resection outcomes, progression-related outcomes, survival outcomes, and safety.

Interventions

Drug Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib
Surgery followed by Hepatic Arterial Infusion Chemotherapy Combined wit Adebrelimab plus Rivoceranib

Primary outcome measures

Time to Treatment Failure [Time frame: 24 months]

Secondary outcome measures (4)

OS [Time frame: 24 months]
R0 rate [Time frame: 24 months]
pCR rate [Time frame: 24 months]
ORR [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

1\. Voluntarily signed written informed consent.
2\. Age ≥18 years; male or female.
3\. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria.
4\. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus).
5\. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1-Vp3), HVTT, or IVCTT.
6\. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy.
7\. Child-Pugh class A liver function.
8\. ECOG performance status 0-1.
9\. Adequate organ function:

ANC ≥1.5 × 10\^9/L; Platelet count ≥75 × 10\^9/L; Hemoglobin ≥90 g/L.
Albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance >50 mL/min.
INR ≤2.3 or PT prolongation ≤6 seconds.
Urine protein <2+; if ≥2+, 24-hour urine protein <1.0 g.
10\. For patients with active HBV infection, effective antiviral therapy is required, with HBV DNA ≤2000 IU/mL or a ≥10-fold reduction after antiviral treatment.
11\. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after study completion. Male participants must also use effective contraception during the study and for 6 months after study completion.

Exclusion criteria

1\. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC).
2\. Severe allergy to iodinated contrast agents that prevents HAIC treatment.
3\. Planned or prior organ transplantation or allogeneic bone marrow transplantation.
4\. Treatment with another investigational drug within 28 days before study treatment.
5\. Current or prior central nervous system metastases.
6\. History of hepatic encephalopathy.
7\. Current interstitial pneumonitis or interstitial lung disease.
8\. Active autoimmune disease or history of autoimmune disease with risk of recurrence.
9\. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment.
10\. Severe infection within 4 weeks before study treatment.
11\. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding.
12\. Known hereditary or acquired bleeding disorders or thrombotic tendency.
13\. Uncontrolled clinically significant cardiac disease or symptoms.
14\. Moderate or severe ascites requiring therapeutic drainage or paracentesis.
15\. Major vascular disease within 6 months before study treatment.
16\. Inability to swallow oral medication, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
17\. Known hypersensitivity to any study drug, its excipients, monoclonal antibodies, or anti-angiogenic agents.
18\. Any other serious acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with study results, or make the patient unsuitable for participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

China · 1 center

Affiliated Hospital of Guangdong Medical University — Zhanjiang

Identifiers

NCT: NCT07684040 · PJKT2026-198

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗