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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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).
ORR
The percentage of subjects achieving complete response (CR) or partial response (PR).
Time frame: up to 2 years
DCR
The percentage of subjects achieving complete response (CR), partial response (PR), or stable disease (SD).
Time frame: up to two years
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.
Time frame: up to two years
OS
The time from the initiation of treatment to death from any cause in subjects.
Time frame: up to two years
6-month PFS rate
The percentage of patients with no progression at 6 months of treatment.
Time frame: up to six months
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.
Time frame: up to two years
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