New cocktail of drugs and radiation targets Hard-to-Treat sarcoma
NCT ID NCT07205185
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of the immunotherapy epalrotokewali, chemotherapy eribulin, targeted therapy anlotinib, and radiotherapy in 46 people with advanced soft tissue sarcoma that has progressed after prior treatment. The goal is to see if this mix can shrink tumors or slow the disease. Researchers will monitor safety and how well patients respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Epalrotokewali (QL1706) plus eribulin, anlotinib, and radiotherapy
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced soft tissue sarcoma that has stopped responding to standard therapies.
- What could go wrong
- This is an early phase 2 trial with only 46 participants, so results may not apply broadly. The combination also carries risks of serious side effects from the drugs and radiation.
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 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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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14 to 75 years
- 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: * Signed informed consent form; * Subjects aged 14-75 years; * Patients with histologically or cytologically confirmed advanced soft tissue sarcoma (STS); * Patients with STS who have failed first-line or higher treatment; * At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); * ECOG performance status (PS) score of 0-1; * Adequate organ and bone marrow function, with laboratory tests meeting the following criteria within 7 days prior to the first dose of study drug (without having received any blood components, hematopoietic growth factors, albumin, or other medications considered corrective therapy by the investigator within 14 days prior to testing): i. Hematology: Hemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥90×10⁹/L. ii. Biochemistry: Serum creatinine (Cr) ≤1.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN for subjects without liver metastases, and ALT and AST ≤5.0×ULN for subjects with liver metastases; serum albumin (ALB) ≥25 g/L. iii. Coagulation function: International normalized ratio (INR) ≤1.5×ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for subjects receiving prophylactic anticoagulation therapy, the investigator should assess that INR and APTT are within safe and effective therapeutic ranges); * Women of childbearing potential must use reliable contraception from screening until 3 months after discontinuation of trial medication, and have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Men must agree to use appropriate contraception or have undergone surgical sterilization from screening until 3 months after discontinuation of trial medication; * Expected survival time ≥12 weeks. Exclusion Criteria: * History of allergy to QL1706 or any of its components, or contraindication to its treatment; * Prior administration of QL1706 or eribulin; * Specific pathological subtypes, such as Ewing sarcoma, non-poly-morphic rhabdomyosarcoma, or gastrointestinal stromal tumor (GIST); * Resistance or intolerance to anlotinib, eribulin, radiotherapy, or any other contraindications to these treatments; * Use of any other investigational drug within 4 weeks prior to screening or participation in another clinical trial; * Diagnosis of immunodeficiency or ongoing systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first trial treatment; * Known history of active Mycobacterium tuberculosis (TB) infection; * Known history of human immunodeficiency virus (HIV) infection; * Active brain metastases or meningeal metastases; * Uncontrolled hypertension (systolic blood pressure \[SBP\] ≥140 mmHg or diastolic blood pressure \[DBP\] \>90 mmHg despite optimal medical therapy); * Severe cardiovascular disease: myocardial ischemia of grade II or higher, myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450 ms in males or ≥470 ms in females); NYHA class III-IV heart failure, or left ventricular ejection fraction (LVEF) \<50% as assessed by echocardiography; * Respiratory syndrome (dyspnea of CTCAE grade ≥2), or uncontrolled serous cavity effusion (including pleural effusion, ascites, or pericardial effusion); * Active hepatitis C and/or hepatitis B infection (hepatitis B: HBsAg-positive with HBV DNA ≥500 IU/mL; hepatitis C: HCV RNA-positive); * Major surgical procedure, severe traumatic injury, fracture, or ulcer within 4 weeks prior to randomization; * History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), vascular thrombosis associated with antiphospholipid syndrome (APS), Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome (GBS), multiple sclerosis (MS), vasculitis, or glomerulonephritis; * Medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results, prevent the subject from completing the study, or other conditions deemed unsuitable for study participation by the investigator.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.
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