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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. | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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 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.

NCT07205185•Fudan University

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

14 - 75 years

Sex

ALL

Healthy Volunteers

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);
+2 more criteria

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);
+6 more criteria

Key Dates

Start Date

October 1, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

October 3, 2025

Enrollment

ESTIMATED participants

Conditions

Soft Tissue Sarcoma (STS)

Interventions

QL1706 + Eribulin + Anlotinib + Radiotherapy

DRUG

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

NCT07432932

SarcomaSarcoma, Leiomyo-, Adult+10 more

View study

NOT_YET_RECRUITINGEARLY_PHASE1

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

NCT07038278

Soft Tissue Sarcoma (STS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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.

Inclusion Criteria

Exclusion Criteria

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells

A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With the PraG Strategy for the Treatment of Soft Tissue Sarcoma

Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma