Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma

NCT07548177 | Recruiting Phase 2

• 1 other identifier: TQB2450-ALTN-II-04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 15

Brief 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).

Conditions

Alveolar Soft Part Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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)

  The period from baseline to the end of the trial is expected to be 32 months.

Secondary Outcomes (15)

• Disease control rate (IRC assessment)

  The period from baseline to the end of the trial is expected to be 32 months.

• Duration of remission (IRC assessment)

  The period from baseline to the end of the trial is expected to be 32 months.

• Progression-free survival (IRC assessment)

  The period from baseline to the end of the trial is expected to be 32months.

• 12-month progression-free survival rate (IRC assessment)

  From baseline to 12 months after treatment

• 24-month progression-free survival rate (IRC assessment)

  From baseline to 24 months after treatment

Study Arms (1)

Benmelstobart injection+Anlotinib Hydrochloride Capsules

EXPERIMENTAL

Benmelstobart injection combined with Anlotinib hydrochloride capsules, with a 21-day cycle.

Drug: Benmelstobart injection combined with Anlotinib hydrochloride capsule

Interventions

Benmelstobart injection combined with Anlotinib hydrochloride capsule DRUG

Benmelstobart is a PD-L1 immunosuppressant. Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Benmelstobart injection+Anlotinib Hydrochloride Capsules

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Absolute neutrophil count (NEUT) ≥ 1.5×109/L;
• Platelet count (PLT) ≥ 100×109/L.
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If there is liver metastasis, ALT and AST ≤ 5 ULN;
• Serum creatinine (CR) ≤ 1.5 ULN or creatinine clearance rate (CCR) ≥ 60ml/min;
• Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (if not receiving anticoagulant therapy);
• Thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, the subject can be included.

You may not qualify if:

• Any subject meeting any of the following criteria will be excluded from this trial:
• 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).
• 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.
• Having active tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms.
• Having a history of substance abuse of psychotropic drugs and being unable to quit or having a mental disorder.
• Preparing for or having previously received allogeneic bone marrow transplantation or solid organ transplantation.
• Having major cardiovascular diseases, including any of the following conditions:
• Cardiac insufficiency of New York Heart Association Functional Classification (NYHA) class II or above or echocardiography showing left ventricular ejection fraction (LVEF) \< 50%;
• History of clinically significant ventricular arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia) or arrhythmias requiring continuous antiarrhythmic drug treatment;
• Unstable angina pectoris;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (15)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China

Chongqing, Chongqing Municipality, 400038, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangdong, Guangdong, 510060, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

NOT YET RECRUITING

The first hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, 830000, China

NOT YET RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine.

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

MeSH Terms

Conditions

Sarcoma, Alveolar Soft Part

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Jiayong Liu, Doctor

CONTACT

13641103227; liujiayong@aliyun.com

Jing Chen, Doctor

CONTACT

15807183251; chenjingunion@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2025-11

Locations

CN (15)