Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the … (NCT07548177) | Clinical Trial Compass
RecruitingPhase 2
Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
China33 participantsStarted 2026-04-02
Plain-language summary
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).
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Pathologically confirmed recurrent and/or metastatic or unresectable alveolar soft part sarcoma, without previous systemic treatment;
✓. Confirmed to have at least one measurable lesion according to RECIST 1.1;
✓. Laboratory tests meet the following standards:
✓. Hemoglobin (HGB) ≥ 90g/L;
Exclusion criteria
✕. 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.).
What they're measuring
1
Objective response rate (IRC assessment)
Timeframe: The period from baseline to the end of the trial is expected to be 32 months.
Trial details
NCT IDNCT07548177
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. 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).
✕. Having experienced any bleeding or hemorrhagic event ≥ CTCAE grade 3 within 4 weeks before the first administration of the drug.
✕. Having experienced an arterial or venous thrombotic event within 6 months before the first administration of the drug, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
✕. Active viral hepatitis that is not well controlled. Subjects meeting the following requirements can be screened: HBsAg-positive subjects must have Hepatitis B Virus (HBV) DNA quantification \< 2000 IU/ml (or 1\*104 copies/ml) or have received at least 1 week of antiviral treatment for HBV before the start of the study and have a 10-fold (1 log value) or greater reduction in viral index, and be willing to receive antiviral treatment throughout the study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by the investigator to be in a stable state or receiving antiviral treatment at the time of enrollment and continuing to receive approved antiviral treatment during the study.
✕. Active syphilis infection requiring treatment.