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The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus TACE) or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study

21. juli 2026 opdateret af: Shanghai Zhongshan Hospital

The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study

This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1/L1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1/L1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, Kina
        • Zhujiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, Kina
        • Sun Yat-sen Memorial Hospital
    • Guangxi
      • Nanning, Guangxi, Kina
        • The First Affiliated Hospital of Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Harbin Medical University Cancer Hospital
        • Kontakt:
    • Shandong
      • Qingdao, Shandong, Kina
        • The Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina
        • Zhong Shan Hospital Fudan University
    • Yunan
      • Kunming, Yunan, Kina
        • Yunnan Cancer Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy (TACE or HAIC) as first line treatment.

Beskrivelse

Inclusion Criteria:

  • Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024.
  • Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology/cytology.
  • Age ≥18 years, regardless of sex.
  • No prior systemic therapy before the administration of donafenib, anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC).
  • The maximum interval between the initiation of donafenib, anti-PD-1/L1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression.
  • For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery.
  • At least one evaluable lesion (according to RECIST v1.1 criteria).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.
  • Child-Pugh class A or B.
  • Adequate major organ function, defined by the following criteria:

Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor [G-CSF] within 14 days prior to screening):

  1. Hemoglobin ≥90 g/L;
  2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L;

  3. Platelet count ≥75×10⁹/L;

    - Blood biochemistry (without albumin use within 14 days prior to screening):

  4. Albumin ≥28 g/L;
  5. Total bilirubin ≤2× upper limit of normal (ULN);
  6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN;
  7. Alkaline phosphatase (ALP) ≤5× ULN;

  8. Creatinine ≤1.5× ULN;

    - Coagulation function:

  9. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;
  10. Activated partial thromboplastin time (APTT) ≤1.5× ULN.

Exclusion Criteria:

  • Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up;
  • Duration of donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month;
  • Prior histologically/cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components;
  • History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group A
Donafenib +PD-1/L1+TACE
Medicin: Donafeinib
Donafenib: 200mg Bid, or follow medical order
Procedure: Transcatheter arterial chemoembolization
Follow medical order
Medicin: PD-1 / PD-L1 monoclonal antibody
Follow Drug instructions or medical order
GROUP B
Donafenib +PD-1/L1+HAIC
Medicin: Donafeinib
Donafenib: 200mg Bid, or follow medical order
Medicin: PD-1 / PD-L1 monoclonal antibody
Follow Drug instructions or medical order
Procedure: Hepatic Artery Infusion Chemotherapy
Follow medical orders

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
progression free survival(PFS)
Tidsramme: Up to approximately 2 year
Progressive disease is measured according to modified Response Evaluation Criteria in Solid Tumors
Up to approximately 2 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate（ORR）
Tidsramme: up to approximately 2 years
CR+PR，measured according to modified Response Evaluation Criteria in Solid Tumors
up to approximately 2 years
Disease control rate（DCR）
Tidsramme: up to approximately 2 years
CR+PR+SD, measured according to modified Response Evaluation Criteria in Solid Tumors
up to approximately 2 years
Overall Survival (OS）
Tidsramme: up to approximately 2 years
up to approximately 2 years
Duration of Response（DOR）
Tidsramme: up to approximately 2 years
up to approximately 2 years
Safety（incidence of AEs ）
Tidsramme: up to approximately 2 years
Adverse events (AEs), adverse reactions and safety laboratory parameters occurring during the treatment period will be summarized according to CTCAE V5.0 grading. The incidence of AEs will be calculated, and the frequency and number of AEs will be listed by system organ class (SOC) with percentages calculated.
up to approximately 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Zhongshan Hospital

Samarbejdspartnere

Yunnan Cancer Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. juli 2026

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2026-120

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Ingen

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Betingelser

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Placeringer

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