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Exploratory Study on Toripalimab and Anlotinib Combined With Standard Chemotherapy for Refractory Dermatofibrosarcoma Protuberans

12 juni 2026 bijgewerkt door: Yanjie Zhang, MD
This study aims to evaluate the efficacy and safety of toripalimab and anlotinib hydrochloride combined with standard chemotherapy in patients with refractory dermatofibrosarcoma protuberans (DFSP) resistant to imatinib therapy, and to provide evidence for the exploration of DFSP treatment.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria

  1. Male or female patients aged ≥18 years.
  2. Locally advanced, unresectable or metastatic dermatofibrosarcoma protuberans (DFSP) with histologically confirmed specific subtypes; disease progression following standard imatinib therapy, or no satisfactory alternative treatment options. Specific subtypes include: fibrosarcomatous DFSP (FS-DFSP) or DFSP with transformation to high-grade sarcoma, such as undifferentiated pleomorphic sarcoma, leiomyosarcoma, rhabdomyosarcoma, etc.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. At least one measurable lesion at baseline according to RECIST 1.1 criteria.

  5. Adequate organ and bone marrow function within 14 days prior to enrollment:

    • Hemoglobin ≥9 g/dL
    • Platelet count ≥75,000/mm³
    • Absolute neutrophil count ≥1500/mm³
    • Serum albumin ≥2.5 g/dL
    • PT, aPTT, and INR ≤1.5 × ULN
    • AST and ALT ≤3 × ULN, or <5 × ULN in patients with liver metastases
    • Total bilirubin ≤1.5 × ULN (without liver metastasis), or <3 × ULN (with Gilbert syndrome or liver metastasis at baseline)
    • Creatinine clearance ≥30 mL/min calculated by the Cockcroft-Gault formula
  6. Left ventricular ejection fraction (LVEF) ≥50% as assessed by ECHO or MUGA scan within 28 days prior to enrollment.

Exclusion Criteria

Patients with any of the following will be excluded:

  1. Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases.
  2. Active primary immunodeficiency, known HIV infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  3. History of non-infectious interstitial lung disease (ILD)/non-infectious pneumonitis requiring corticosteroid therapy, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging at screening.
  4. Myocardial infarction within 6 months prior to enrollment, symptomatic congestive heart failure (CHF, NYHA class II-IV), unstable angina, or recent cardiovascular event (including stroke) within <6 months.

  5. Pulmonary criteria:

    1. Clinically significant pulmonary comorbidities including but not limited to underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, pleural effusion within 3 months before enrollment);
    2. Documented autoimmune, connective tissue, or inflammatory disease (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) or suspected pulmonary involvement at screening; full disease details must be documented in the eCRF;
    3. Prior pneumonectomy.
  6. Poor compliance unable to cooperate with study treatment and procedures.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Toripalimab, Anlotinib Hydrochloride Combined with Standard Chemotherapy
All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: Toripalimab 240 mg (fixed dose) administered intravenously once every 3 weeks (Q3W); Anlotinib 10 mg administered orally once daily on Days 1-14 of each 3-week cycle; and standard chemotherapy based on anthracycline or gemcitabine once every 3 weeks (Q3W).
Geneesmiddel: Toripalimab
All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: Toripalimab 240 mg (fixed dose) administered intravenously once every 3 weeks (Q3W).
Geneesmiddel: Anlotinib
All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: Anlotinib 10 mg administered orally once daily on Days 1-14 of each 3-week cycle.
Geneesmiddel: Standard Chemotherapy
All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: standard chemotherapy based on anthracycline or gemcitabine once every 3 weeks (Q3W).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (ORR)
Tijdsspanne: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Response (DoR)
Tijdsspanne: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first, assessed up to 24months.
Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first, assessed up to 24months.
Progression-Free Survival (PFS)
Tijdsspanne: Through study completion, an average of 2 years.
Progression-Free Survival (PFS) is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1.
Through study completion, an average of 2 years.
Overall Survival (OS)
Tijdsspanne: Through study completion, an average of 2 years.
Overall Survival (OS) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.
Through study completion, an average of 2 years.
Disease Control Rate (DCR)
Tijdsspanne: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or SD maintained more than 8 weeks. Tumor responses were assessed by investigators using RECIST version 1.1.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Best Overall Response (BOR)
Tijdsspanne: Through study completion, average follow-up of 2 years.
Best overall response (BOR) is defined as the best tumor response achieved at any time during treatment, categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) per RECIST 1.1 criteria. Responses require confirmation at least 4 weeks later.
Through study completion, average follow-up of 2 years.
Time to Response (TTR)
Tijdsspanne: From first dose until first confirmed response, assessed up to 48 months.
Time to response (TTR) is defined as the time from the date of first study drug administration to the date of first documented and confirmed CR or PR per RECIST 1.1.
From first dose until first confirmed response, assessed up to 48 months.
Adverse Events (AEs)
Tijdsspanne: From first study drug administration through 40 days after the last dose; overall average follow-up duration is 2 years.
Incidence, severity (graded per NCI CTCAE version 5.0), and causality of adverse events (AEs). Special attention will be paid to AEs of special interest associated with toripalimab, anlotinib, and anthracycline- or gemcitabine-based chemotherapy, including myelosuppression, hypertension, diarrhea, rash, liver function abnormalities, endocrine disorders, and cardiac toxicity (monitored via periodic left ventricular ejection fraction and electrocardiography).
From first study drug administration through 40 days after the last dose; overall average follow-up duration is 2 years.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yanjie Zhang, MD

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juni 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

14 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • JY2026-036

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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