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Dermatofibrosarcoma Protuberans (DFSP)Phase 2NCT07646080

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

A Phase 2 study testing Toripalimab, Anlotinib and Standard Chemotherapy in people with Dermatofibrosarcoma Protuberans (DFSP), run by Yanjie Zhang, MD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatofibrosarcoma Protuberans (DFSP)
What is being tested?
Toripalimab, Anlotinib and Standard Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
15 Jun 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥18 years.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • At least one measurable lesion at baseline according to RECIST 1.1 criteria.
  • Adequate organ and bone marrow function within 14 days prior to enrollment:
  • Hemoglobin ≥9 g/dL
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  • 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
  • Left ventricular ejection fraction (LVEF) ≥50% as assessed by ECHO or MUGA scan within 28 days prior to enrollment.

Who cannot join

  • Patients with any of the following will be excluded:
  • Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases.
  • Active primary immunodeficiency, known HIV infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • 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.
  • 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.
  • Pulmonary criteria:
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  • 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);
  • 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;
  • Prior pneumonectomy.
  • Poor compliance unable to cooperate with study treatment and procedures.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Haihua Yuan contact

+86-021-56691101-7261

ayuan790415@shsmu.edu.cn

About this study

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.

Being tested
Toripalimab, Anlotinib, Standard Chemotherapy
Medical subject headings
Dermatofibrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    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).

  • AnlotinibDrug

    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.

  • Standard ChemotherapyDrug

    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).

Study groups in NCT07646080
Study groupRoleWhat they receive
Toripalimab, Anlotinib Hydrochloride Combined with Standard ChemotherapyExperimentalAll 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).
Receives: Drug: Toripalimab; Drug: Anlotinib; Drug: Standard Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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.

    Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.

Secondary outcomes (7)

  1. Duration of Response (DoR)

    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.

    Measured: 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.

  2. Progression-Free Survival (PFS)

    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.

    Measured: Through study completion, an average of 2 years.

  3. Overall Survival (OS)

    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.

    Measured: Through study completion, an average of 2 years.

  4. Disease Control Rate (DCR)

    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.

    Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

  5. Best Overall Response (BOR)

    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.

    Measured: Through study completion, average follow-up of 2 years.

  6. Time to Response (TTR)

    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.

    Measured: From first dose until first confirmed response, assessed up to 48 months.

  7. Adverse Events (AEs)

    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).

    Measured: From first study drug administration through 40 days after the last dose; overall average follow-up duration is 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07646080
Sponsor's protocol ID
JY2026-036
Status last verified
Jun 2026
First submitted
14 Apr 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab, Anlotinib and Standard Chemotherapy in people with Dermatofibrosarcoma Protuberans (DFSP), run by Yanjie Zhang, MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haihua Yuan (+86-021-56691101-7261, ayuan790415@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07646080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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