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

12 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Médicament: 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).
Médicament: 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.
Médicament: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Duration of Response (DoR)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Yanjie Zhang, MD

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

14 avril 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • JY2026-036

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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