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New treatment option for Alveolar Soft Part Sarcoma
Official title Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma
ClinicalTrials.gov ID: NCT07548177
What this study is testing
What is Benmelstobart injection combined with Anlotinib hydrochloride capsule?
Benmelstobart injection combined with Anlotinib hydrochloride capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alveolar soft part sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Only when all the following criteria are met will the people be eligible for inclusion in this study:
- The people 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;
You likely can't join if
- Any subject meeting any of the following criteria will be excluded from this trial:
- Having had or currently having another malignant tumor within 5 years before the first administration of the drug. The following two situations are...
- Having diseases that affect intravenous injection or blood collection, or having multiple factors that affect oral medication (such as inability to...
- Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1...
- Having undergone major surgery, significant traumatic injury, or expected to undergo major surgery during the study period within 4 weeks before the...
- Having experienced any bleeding or hemorrhagic event ≥ CTCAE grade 3 within 4 weeks before the first administration of the drug.
See the full eligibility criteria
Who can join
- Only when all the following criteria are met will the people be eligible for inclusion in this study:
- The people 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.
- Women of childbearing age must agree to use effective contraceptive measures during the study and for 6 months after the study, and have a negative serum test within 7 days before study enrollment; men must agree to use...
What rules you out
- Any subject meeting any of the following criteria will be excluded from this trial:
- 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...
- 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...
- 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...
- 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...
- Active viral hepatitis that is not well controlled. people meeting the following requirements can be screened: HBsAg-positive people must have Hepatitis B Virus (HBV) DNA quantification \< 2000 IU/ml (or 1\ 104...
- 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...
- Unstable angina pectoris;
- Myocardial infarction within 12 months;
- Fridericia-corrected QT interval (QTcF) \> 450 milliseconds (msec) for men and \> 470 msec for women (if QTc is abnormal, it can be continuously measured three times with an interval of more than 2 minutes, and the...
- History or family history of congenital long QT syndrome. 7) A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolic event within 3 months prior to randomization (implantable venous...
- Currently using or having used within 7 days prior to the start of study treatment aspirin (\>325 mg/day (maximum antiplatelet dose)), dipyridamole, ticlopidine, clopidogrel, or cilostazol;
- Active or uncontrolled severe infection (≥CTC AE grade 2 infection);
- Renal failure requiring hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
- people who need to use immunosuppressants, systemic or absorbable local hormones for immunosuppression purposes and will continue to do so within 7 days before the first administration (except for glucocorticoids at a...
- Patients with epilepsy requiring treatment;
- Tumor-related symptoms and treatment:
- Having received treatment with traditional Chinese patent medicines with clear anti-tumor indications in the National Medical Products Administration (NMPA)-approved drug instructions (including Compound Cantharidin...
- Having received previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, or Cytotoxic T-Lymphocyte-Associated Antigen 4 (CTLA-4);
- Having previously used anti-angiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, or fruquintinib;
- Having received treatment with drugs with immunomodulatory functions (such as interleukin-2, thymosin, polysaccharides from Lentinus edodes, etc.) within 30 days prior to the start of treatment;
- Not having recovered from the toxicity and/or complications of previous interventions to CTCAE ≤ grade 1, except for alopecia and peripheral neuropathy ≤ grade 2. ；
- Imaging studies (CT or MRI) show that the tumor has invaded major blood vessels or the investigator deems that the tumor is highly likely to invade major blood vessels and cause fatal hemorrhage during the subsequent...
- Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites (as judged by the investigator) that requires repeated drainage;
- Known to have spinal cord compression, carcinomatous meningitis, brain metastases with symptoms or symptoms controlled for less than 4 weeks.
- Known to be allergic to the excipients of the study drug.
- Participants who have taken part in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration of the study drug.
- As judged by the investigator, there are serious conditions that endanger the safety of the participant or affect the participant's completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangdong, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangdong, Guangdong, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.