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HAIC vs. TACE Combined With Sintilimab and Bevacizumab for Intermediate HCC (Beyond Up-To-Seven)

2026年5月19日 更新者：Binkui Li

Hepatic Arterial Infusion Chemotherapy Plus Sintilimab and Bevacizumab Versus Transarterial Chemoembolization Plus Sintilimab and Bevacizumab for Intermediate-Stage Hepatocellular Carcinoma Beyond the Up-To-Seven Criteria：A Prospective, Randomized, Controlled Trial

The purpose of this prospective, randomized, multicenter, controlled clinical study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared to transarterial chemoembolization (TACE) when both are combined with sintilimab and bevacizumab for patients with intermediate-stage hepatocellular carcinoma (HCC). Specifically, the trial focuses on patients with a high tumor burden that exceeds the Up-To-Seven criteria.While TACE is the standard treatment for BCLC stage B HCC, its effectiveness is often limited in patients with extensive intrahepatic tumor loads. This study investigates whether the combination of FOLFOX-HAIC and systemic therapy (sintilimab plus bevacizumab) provides better local control and survival outcomes than the combination of TACE and the same systemic therapy.

Experimental Group: Patients receive FOLFOX-HAIC (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Control Group: Patients receive on-demand TACE (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Primary Objective: To compare Progression-Free Survival (PFS) between the two arms as evaluated by mRECIST. Enrollment: A total of 300 patients will be randomized at a 1:1 ratio to the treatment groups. The study aims to provide high-level clinical evidence for optimizing treatment strategies for this specific subgroup of HCC patients.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

300

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • 募集
        • Sun Yat-sen University Cancer Center
        • コンタクト：
        • 主任研究者：
          • Binkui Li

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Diagnosis: Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients with cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
  • Age: ≥ 18 years old.
  • Performance Status: ECOG performance status score of 0.
  • Prior Treatment: No prior systemic anti-tumor therapy or transarterial interventional therapy for HCC.
  • Tumor Stage and Burden: Barcelona Clinic Liver Cancer (BCLC) Stage B, unsuitable for radical surgery and/or local therapy (such as ablation).
  • Up-To-Seven Criteria: Tumor burden exceeding the Up-To-Seven criteria, defined as the sum of the size of the largest intrahepatic tumor (in cm) and the number of tumors being greater than 7.
  • Tumor Distribution: Bilobar multifocal tumors.
  • Measurable Disease: At least one measurable lesion with arterial phase enhancement on CT/MRI.
  • Vascular Status: Patent portal vein with no evidence of portal vein tumor thrombus.
  • Extrahepatic Status: No extrahepatic metastasis.
  • Variceal Risk: No risk of variceal bleeding; esophagogastroduodenoscopy (EGD) within 6 months shows no gastroesophageal varices or active ulcers.
  • Liver Function: Child-Pugh Grade A.
  • Hematology: Platelets > 75 × 10⁹/L; White Blood Cells > 3.0 × 10⁹/L; Neutrophils > 1.5 × 10⁹/L.
  • Biochemistry: Serum bilirubin ≤ 1.5 × upper limit of normal (ULN); Transaminases ≤ 3 × ULN; Serum creatinine < 1.5 × ULN.
  • Physical Findings: No ascites
  • Albumin ≥ 30 g/L.
  • Coagulation: Normal coagulation function.
  • Expectancy: Expected survival > 3 months.
  • Consent: Signed written informed consent and willingness/ability to comply with follow-up until death, study completion, or termination.

Exclusion Criteria:

  • Histology: Known histology/cytology of fibrolamellar HCC, sarcomatoid HCC, or components of cholangiocarcinoma.
  • Medical History: History of hepatic encephalopathy or liver transplantation.
  • Effusions: Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
  • Viral Hepatitis: Active Hepatitis B (HBV DNA > 2000 IU/ml or 10⁴ copies/ml) or Hepatitis C (HCV RNA > 10³ copies/ml); co-infection with both HBsAg and anti-HCV positive. (Eligible if levels drop below these criteria after nucleoside antiviral therapy) .
  • Cardiovascular (Past 12 Months): Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism.
  • Ongoing Cardiac Issues: Arrhythmia ≥ Grade 2 (NCI-CTCAE); QTc prolongation (Male > 450 ms, Female > 470 ms).
  • Bleeding Risk: History of gastrointestinal bleeding within 6 months or clear bleeding tendency (e.g., high-risk varices, active GI ulcer, persistent positive fecal occult blood).
  • Hypertension: Uncontrollable hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite optimal treatment); history of hypertensive crisis or hypertensive encephalopathy.
  • Organ Failure: Renal failure requiring hemodialysis or peritoneal dialysis; severe dysfunction of other major organs.
  • Second Malignancy: History of other malignancies within 3 years prior to screening (except those with negligible risk of metastasis/death such as treated cervical cancer in situ, non-melanoma skin cancer, or localized prostate cancer).
  • CNS Involvement: Known or new evidence of brain or leptomeningeal lesions. Coagulation Disorders: Hemophilia or bleeding tendency; currently taking therapeutic doses of coumarin derivatives (e.g., warfarin).
  • Pregnancy/Lactation: Pregnant or breastfeeding females; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
  • Other History: Prior organ transplant; known HIV infection; active tuberculosis; allergy to chemotherapy drugs.
  • Autoimmune Diseases: Active or history of autoimmune diseases (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, rheumatoid arthritis, IBD, etc.).
  • General Compliance: Any serious acute/chronic physical or mental illness, or laboratory abnormalities that increase study risk or interfere with interpretation of results.
  • Non-compliance: History of significant non-compliance with medical protocols or inability to provide reliable informed consent.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：FOLFOX-HAIC Combination

Intervention:

Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h).
手順：Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks.
Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h).
アクティブコンパレータ：TACE Combination

Intervention:

Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml).
手順：TACE (transarterial chemoembolization) combined with targeted/immunotherapy
Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression-Free Survival
時間枠：From date of randomization until the date of first documented progression (per mRECIST) or date of death from any cause, assessed up to 5 years.
Progression-Free Survival (PFS): From randomization to first documentation of progression (mRECIST) or death from any cause.
From date of randomization until the date of first documented progression (per mRECIST) or date of death from any cause, assessed up to 5 years.

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival
時間枠：From date of randomization until the date of death from any cause, assessed up to 5 years.
Overall Survival (OS): From randomization to death from any cause.
From date of randomization until the date of death from any cause, assessed up to 5 years.
Objective Response Rate
時間枠：From date of randomization until the end of systemic treatment (up to 12 months).
Objective Response Rate (ORR): Proportion of patients with CR or PR per mRECIST and RECIST 1.1.
From date of randomization until the end of systemic treatment (up to 12 months).
Disease Control Rate
時間枠：From date of randomization until the end of systemic treatment (up to 12 months).
Disease Control Rate (DCR): Proportion of patients with CR, PR, or SD.
From date of randomization until the end of systemic treatment (up to 12 months).
Duration of Response
時間枠：From initial response (CR or PR) to the date of first documented progression or death，assessed up to 5 years.
From initial response (CR or PR) to the date of first documented progression or death
From initial response (CR or PR) to the date of first documented progression or death，assessed up to 5 years.
Time to Progression
時間枠：From date of randomization to the date of first objective tumor progression, assessed up to 5 years.
From date of randomization to the date of first objective tumor progression
From date of randomization to the date of first objective tumor progression, assessed up to 5 years.
Conversion Rate
時間枠：From date of randomization until the end of the conversion therapy assessment (typically within 12 months).
Conversion Rate: Percentage of patients achieving surgical resection eligibility.
From date of randomization until the end of the conversion therapy assessment (typically within 12 months).
Safety Profile
時間枠：From randomization until 1 year after the last dose of study treatment.
Safety Profile: Incidence of adverse events per NCI CTCAE v5.0.
From randomization until 1 year after the last dose of study treatment.
Patient-Reported Outcomes
時間枠：Baseline and every 1 month until the end of month 12.
Patient-Reported Outcomes (PRO): Quality of life using IL42-EORTC QLQ-C30.
Baseline and every 1 month until the end of month 12.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Binkui Li

捜査官

  • 主任研究者：Binkui Li、Sun Yat-sen University Cancer Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月15日

一次修了 (推定)

2030年5月30日

研究の完了 (推定)

2030年5月30日

試験登録日

最初に提出

2026年5月12日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月19日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • B2026-143-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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