Actively Recruiting
To Evaluate Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in Advanced or Unresectable Alveolar Soft Part Sarcoma: A Single-arm, Multi-center Phase II Clinical Trial
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-04-23
33
Participants Needed
15
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of benmelstobart injection and anlotinib hydrochloride capsules in patients aged 14 years or older with advanced or unresectable alveolar soft part sarcoma. This Phase II, single-arm, multicenter clinical study aims to assess the objective response rate based on independent review committee (IRC) assessment. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and is designed to explore treatment options for this rare type of cancer without previous systemic therapy. Participants will receive benmelstobart injection combined with anlotinib hydrochloride capsules in 21-day treatment cycles. Benmelstobart acts as a PD-L1 immunosuppressant, while anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor. The study does not include a comparison group and follows a single-arm design, focusing on evaluating the treatment effect over time. Throughout the expected 32-month trial period, participants will undergo regular evaluations to measure outcomes such as objective response rate, disease control rate, duration of remission, and progression-free survival, assessed both by IRC and researchers. Follow-up includes survival monitoring up to an estimated 48 months from baseline. Safety is monitored by recording adverse events and laboratory tests. Participants will be closely observed for treatment effects and side effects during and after treatment.
CONDITIONS
Brief Title
Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily join the study, sign informed consent, and comply with study requirements
- Age 14 years or older at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Expected survival greater than 12 weeks
- Pathologically confirmed recurrent, metastatic, or unresectable alveolar soft part sarcoma without prior systemic treatment
- At least one measurable lesion per RECIST 1.1 criteria
- Laboratory values within specified limits, including hemoglobin 90 g/L, neutrophils 1.5 x 10^9/L, platelets 100 x 10^9/L, liver and kidney function, coagulation, and thyroid function
- Women of childbearing potential must use effective contraception during and for 6 months after the study and have a negative pregnancy test; men must agree to effective contraception during and for 6 months after the study
You will not qualify if you...
- History or current diagnosis of another malignant tumor within 5 years, except certain treated cancers with long disease-free survival
- Conditions affecting intravenous injection, blood collection, or oral medication intake
- Unrecovered adverse reactions from prior treatments, except some mild conditions
- Recent major surgery, trauma, or unhealed wounds within 4 weeks before treatment
- Recent serious bleeding or thrombotic events
- Active uncontrolled infections, including hepatitis, tuberculosis, syphilis
- Mental disorders or substance abuse affecting study participation
- Previous bone marrow or organ transplantation
- Major cardiovascular diseases including heart failure, arrhythmias, unstable angina, recent myocardial infarction, prolonged QT interval
- Use of certain antiplatelet or anticoagulant drugs prior to study
- Immunodeficiency or use of immunosuppressants not allowed
- Prior treatments with immune checkpoint inhibitors or anti-angiogenic drugs
- Tumor invading major blood vessels or causing risk of fatal hemorrhage
- Uncontrolled fluid accumulation such as pleural effusion or ascites
- Brain metastases with symptoms or recent control less than 4 weeks
- Allergies to study drug components
- Participation in other anti-tumor drug trials within 4 weeks
- Any serious condition that could risk safety or study completion as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation, up to approximately 32 months
Participants receive Benmelstobart injection combined with Anlotinib hydrochloride capsules in repeated 21-day cycles as part of their treatment for advanced or unresectable alveolar soft part sarcoma.
Visits every 21 days for treatment administration and assessment
Duration - Up to 16 months after treatment, totaling approximately 48 months from baseline
Participants are monitored for safety and survival outcomes after treatment completion.
Periodic visits for survival and safety assessments
Trial Site Locations
Total: 15 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangdong, Guangdong, China, 510060
Not Yet Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
7
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
8
The first hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
9
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
10
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Not Yet Recruiting
11
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
12
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
13
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
14
The Second Affiliated Hospital, Zhejiang University School of Medicine.
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
15
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
J
Jiayong Liu, Doctor
J
Jing Chen, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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