This is a Phase II, single-arm, multicenter clinical study aimed at demonstrating the effectiveness of benmelstobart injection combined with anlotinib hydrochloride capsules in patients aged 14 years or older with advanced or unresectable alveolar soft part sarcoma by evaluating the objective response rate (IRC).
The subjects voluntarily join this study, sign the informed consent form, and have good compliance;
≥14 years old (calculated from the date of signing the informed consent form);
Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 1;
Expected survival greater than 12 weeks;
Having had or currently having another malignant tumor within 5 years before the first administration of the drug. The following two situations are eligible for inclusion: other malignant tumors treated with a single surgery and achieving a disease-free survival (DFS) of at least 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)].
Having diseases that affect intravenous injection or blood collection, or having multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.).
Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1, except for grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which are judged by the investigator to have no safety risks.
Having undergone major surgery, significant traumatic injury, or expected to undergo major surgery during the study period within 4 weeks before the first administration of the drug (except for surgeries specified in the protocol), or having long-term unhealed wounds or fractures. (Major surgery is defined as: surgeries classified as grade 3 or above in the 2023 version of the surgical classification directory of the participating center).
Single group
Benmelstobart injection combined with Anlotinib hydrochloride capsule
DrugBenmelstobart is a PD-L1 immunosuppressant. Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Objective response rate (IRC assessment)
The proportion of patients with tumor volume reduction reaching 30% is usually the sum of the proportions of complete response (CR) and partial response (PR). (IRC Assessment)
Disease control rate (IRC assessment)
The proportion of cases that achieved remission (CR+PR) and disease stability (SD) after treatment, that is, the proportion of patients who did not experience disease progression (PD). (IRC Assessment)
Duration of remission (IRC assessment)
The duration from the first significant shrinkage of the tumor to its subsequent enlargement/progression (IRC assessment)
Progression-free survival (IRC assessment)
From the time of random initiation to the occurrence of a predetermined event, an event may include death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.(IRC assessment)
12-month progression-free survival rate (IRC assessment)
The proportion of subjects whose condition did not deteriorate or progress from the start of treatment to 12 months (IRC assessment)
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