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

2026년 5월 19일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

300

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510000
        • 모병
        • Sun Yat-sen University Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Binkui Li

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
절차: 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).
활성 비교기: 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).
절차: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Binkui Li

수사관

  • 수석 연구원: Binkui Li, Sun Yat-sen University Cancer Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 15일

기본 완료 (추정된)

2030년 5월 30일

연구 완료 (추정된)

2030년 5월 30일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 12일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 19일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B2026-143-01

개별 참가자 데이터(IPD) 계획

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미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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