New hope for rare skin cancer? drug cocktail targets resistant DFSP
NCT ID NCT07646080
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial will test whether combining two newer drugs (toripalimab and anlotinib) with standard chemotherapy can shrink tumors in people with a rare skin cancer called dermatofibrosarcoma protuberans (DFSP) that has stopped responding to the usual treatment. The study plans to enroll 20 adults with advanced DFSP that cannot be surgically removed. Participants will receive the drug combination in 3-week cycles until their disease worsens or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab and anlotinib combined with standard chemotherapy
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced DFSP that no longer responds to standard therapy.
- What could go wrong
- This is a small, early-phase trial with only 20 participants. The combination may cause significant side effects and may not shrink tumors as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.