A Study of Combination Therapy in Patients With Resectable Liver Cancer

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Time to Treatment Failure [Срок оценки: 24 months]

Вторичные конечные точки (4)

• OS [Срок оценки: 24 months]
• R0 rate [Срок оценки: 24 months]
• pCR rate [Срок оценки: 24 months]
• ORR [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Guangdong Medical University — Zhanjiang

Идентификаторы

NCT: NCT07684040 · PJKT2026-198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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