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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706+ Eribulin + Anlotinib + Radiotherapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 + Eribulin + Anlotinib + Radiotherapy | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The percentage of subjects achieving complete response (CR) or partial response (PR). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | The percentage of subjects achieving complete response (CR), partial response (PR), or stable disease (SD). | 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. |
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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);
Exclusion Criteria:
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| up to two years |
| OS | The time from the initiation of treatment to death from any cause in subjects. | up to two years |
| 6-month PFS rate | The percentage of patients with no progression at 6 months of treatment. | 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. | up to two years |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C490954 | eribulin |
| C000625192 | anlotinib |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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