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Soft Tissue Sarcoma (STS)Phase 2NCT07205185

A Multicenter, Single-arm, Prospective Phase II Clinical Study of Epalrotokewali Combined With Eribulin, Anlotinib, and Radiotherapy for the Treatment of Patients With Advanced Soft Tissue Sarcoma.

A Phase 2 study testing QL1706 + Eribulin + Anlotinib + Radiotherapy in people with Soft Tissue Sarcoma (STS), run by Fudan University.

Not yet recruiting

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

Official record
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Trial summary

This study intends to enroll patients with advanced soft tissue sarcoma, employing immunotherapy combined with eribulin, anlotinib, and radiotherapy as subsequent-line treatment to preliminarily explore its efficacy and safety. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Soft Tissue Sarcoma (STS)
What is being tested?
QL1706 + Eribulin + Anlotinib + Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 31 Dec 2027
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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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):
  • Hematology: Hemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥90×10⁹/L.
  • 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.
  • 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.

Who cannot join

  • 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;
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  • 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.

About this study

Official title: A Multicenter, Single-arm, Prospective Phase II Clinical Study of Epalrotokewali Monotherapy Combined With Eribulin, Anlotinib, and Radiotherapy for the Treatment of Patients With Advanced Soft Tissue Sarcoma.

This study intends to enroll patients with advanced soft tissue sarcoma, employing immunotherapy combined with eribulin, anlotinib, and radiotherapy as subsequent-line treatment to preliminarily explore its efficacy and safety. QL1706, a dual-targeting agent against PD-1 and CTLA-4, has been approved by the National Medical Products Administration (NMPA) of China for the second-line treatment of cervical cancer.

Being tested
QL1706 + Eribulin + Anlotinib + Radiotherapy
Medical subject headings
Sarcoma

What participants receive

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

  • QL1706 + Eribulin + Anlotinib + RadiotherapyDrug

    QL1706: 5 mg/kg, intravenous injection (IV) on Day 1, every 3 weeks (Q3W). Eribulin : 1.1 mg/m², intravenous infusion (IV) on Days 1 and 8, Q3W. Anlotinib : Oral administration before breakfast, 12 mg once daily (QD) on Days 1-14, followed by a 1-week drug holiday, Q3W.

    Radiotherapy : Hypofractionated radiotherapy, 15-60 Gy delivered in 5-8 fractions.

    Eribulin is administered for 6 cycles. Epalizumab and anlotinib are continued until disease progression, intolerable toxicity, initiation of new anti-tumor treatment, loss to follow-up, death, or withdrawal from the study (whichever occurs first).

Study groups in NCT07205185
Study groupRoleWhat they receive
QL1706+ Eribulin + Anlotinib + RadiotherapyExperimentalQL1706:5 mg/kg, intravenous injection (IV) on Day 1, every 3 weeks (Q3W). Eribulin : 1.1 mg/m², intravenous infusion (IV) on Days 1 and 8, Q3W. Anlotinib : Oral administration before breakfast, 12 mg once daily (QD) on Days 1-14, followed by a 1-week drug holiday, Q3W. Radiotherapy : Hypofractionated radiotherapy, 15-60 Gy delivered in 5-8 fractions.
Receives: Drug: QL1706 + Eribulin + Anlotinib + Radiotherapy

What is being measured

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

  1. ORR

    The percentage of subjects achieving complete response (CR) or partial response (PR).

    Measured: up to 2 years

Secondary outcomes (5)

  1. DCR

    The percentage of subjects achieving complete response (CR), partial response (PR), or stable disease (SD).

    Measured: up to two years

  2. PFS

    From the date of enrollment, the date of the first documented tumor progression (assessed by RECIST v1.1 criteria, regardless of whether treatment is continued) or the date of death from any cause, whichever occurs first.

    Measured: up to two years

  3. OS

    The time from the initiation of treatment to death from any cause in subjects.

    Measured: up to two years

  4. 6-month PFS rate

    The percentage of patients with no progression at 6 months of treatment.

    Measured: up to six months

  5. DoR

    For patients who achieved complete response (CR) or partial response (PR), the time from the first tumor assessment documenting response to disease progression or death, whichever occurs first.

    Measured: up to two years

Timeline

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

  1. First posted3 Oct 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (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
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205185
Sponsor's protocol ID
RITEA
Status last verified
Sep 2025
First submitted
25 Sep 2025
Last updated
3 Oct 2025
Results posted
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 QL1706 + Eribulin + Anlotinib + Radiotherapy in people with Soft Tissue Sarcoma (STS), run by Fudan University.

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 12 inclusion and 16 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 3 Oct 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 2 years). 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 NCT07205185.

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 3 Oct 2025.

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