Actively Recruiting
Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-04-23
33
Participants Needed
15
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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...
- Participants must voluntarily join the study, sign informed consent, and have good compliance
- Participants must be 14 years or older
- Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 1
- Expected survival longer than 12 weeks
- Pathologically confirmed recurrent, metastatic, or unresectable alveolar soft part sarcoma without previous systemic treatment
- At least one measurable lesion according to RECIST 1.1 criteria
- Laboratory tests meeting specified standards: hemoglobin ≥90g/L; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; total bilirubin ≤1.5 times upper limit of normal; ALT and AST ≤2.5 times ULN or ≤5 times ULN if liver metastasis present; serum creatinine ≤1.5 ULN or creatinine clearance rate ≥60ml/min; coagulation times ≤1.5×ULN if not on anticoagulants; thyroid stimulating hormone ≤ULN with normal T3 and T4 if abnormal
- Women of childbearing age must agree to effective contraception during the study and for 6 months after, with a negative serum pregnancy test within 7 days before enrollment; men must agree to use effective contraception during the study and for 6 months after
You will not qualify if you...
- History of other malignant tumors within 5 years before starting treatment, except certain cured or low-risk cancers
- Diseases affecting intravenous injection or oral medication ability
- Unresolved adverse reactions from prior treatments above specified severity, except certain mild conditions
- Major surgery, significant trauma, or unhealed wounds/fractures within 4 weeks before treatment start
- Bleeding events of grade 3 or higher within 4 weeks before treatment
- Arterial or venous thrombotic events within 6 months before treatment
- Active uncontrolled viral hepatitis or syphilis infection
- Active tuberculosis, certain lung diseases, or active pneumonia with symptoms
- History of substance abuse or mental disorders preventing study participation
- History or preparation for bone marrow or organ transplantation
- Major cardiovascular diseases including heart failure, arrhythmias, recent myocardial infarction, prolonged QT interval, or recent thromboembolic events
- Severe infection, renal failure requiring dialysis, immunodeficiency including HIV
- Use of immunosuppressants or certain glucocorticoids within 7 days before treatment
- Epilepsy requiring treatment
- Recent use of certain traditional Chinese medicines, immune checkpoint inhibitors, anti-angiogenic drugs, or immunomodulatory treatments
- Tumors invading major blood vessels or causing risk of fatal hemorrhage
- Uncontrolled fluid accumulations requiring repeated drainage
- Known spinal cord compression, carcinomatous meningitis, or symptomatic brain metastases
- Allergy to study drug ingredients
- Participation in other anti-tumor clinical trials within 4 weeks before treatment
- Any serious conditions deemed unsafe or preventing study completion by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jing Chen, Doctor
CONTACT
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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