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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.

NCT07205185 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma (STS)

Interventions

DRUG

QL1706 + Eribulin + Anlotinib + Radiotherapy

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).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07205185 on ClinicalTrials.gov