Anlotinib treatment for advanced soft tissue sarcoma

A Single-arm, Multicentre, Phase II Clinical Trial of Anlotinib Maintenance Treatment After First-line Anthracycline-based Chemotherapy in Advanced Soft Tissue Sarcoma (ALTER-S006)

This study is testing if the drug anlotinib can help people with advanced soft tissue sarcoma stay stable after their initial chemotherapy treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: anlotinib, immunotherapy, Radiation, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03890068 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of anlotinib, a multi-target receptor tyrosine kinase inhibitor, as a maintenance treatment for patients with advanced soft tissue sarcoma following first-line anthracycline-based chemotherapy. The trial aims to include 48 participants who have shown stable disease or partial response after at least four cycles of chemotherapy. Participants will receive anlotinib at a dose of 12 mg once daily in 21-day cycles until disease progression or unacceptable toxicity occurs. The study will assess the drug's ability to maintain disease control in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with pathologically confirmed advanced soft tissue sarcoma who have achieved stable disease or partial response after prior chemotherapy.

Not a fit: Patients with certain types of sarcoma, such as malignant peripheral nerve sheath tumor or rhabdomyosarcoma, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance option for patients with advanced soft tissue sarcoma, potentially improving their disease control and overall survival.

How similar studies have performed: Other studies have shown promising results with similar approaches using anlotinib in treating soft tissue sarcoma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Signed and dated informed consent form prior to patient entry;
* 18-70 years , regardless of gender；ECOG :0-2;Expected Survival Time: Over 3 months;
* Subjects with pathologically confirmed advanced synovial sarcoma, leiomyosarcoma, liposarcoma, angiosarcoma, etc. (except malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, chondrosarcoma, osteosarcoma, dermato- fibrosarcoma protuberans, gastrointestinal stromal tumor, ewing's sarcoma/primitive neuroectodermal tumor, inflammatory myofibroblastic tumor, and malignant mesothelioma);
* Evaluable disease by imaging or physical exam or measurable disease defined as at least one lesion that can be accurately measured according to RECIST version 1.1.
* PR/SD patients after ≥4 cycles anthracyclines treatment .
* Main organs function is normal.(normal main organs function as defined below: Hemoglobin (Hb) ≥ 80g / L, Neutrophils (ANC) ≥ 1.5 × 109 / L, Platelet count (PLT) ≥ 80 × 109 / L, Serum creatinine (Cr) ≤ 1.5 × normal upper limit (ULN) or creatinine clearance (CCr) ≥ 60ml / min, Blood urea nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Total bilirubin (TB) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; If accompanied by liver metastases, ALT and AST ≤ 5 × ULN Albumin (ALB) ≥ 25 g/L. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).)
* The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.

Exclusion Criteria:

* Prior treatment with anlotinib.
* A history of other malignancy ≤ 5 years previous.
* Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
* Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment, excluding alopecia.
* Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
* With pleural effusion or ascites, cause respiratory syndrome. (\> CTC AE grade 2 dyspnea \[grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life\])
* Symptoms of brain metastases cannot be controlled and treated within less than 2 months.
* Thyroid dysfunction after best support treatment.
* With severe and failed to controlled diseases. (including:1)Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose \> 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment.)
* Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.
* The investigator judged that during the follow-up study, the tumor is very likely to invade the important blood vessels and cause fatal hemorrhage, or the formation of tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava)
* Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than CTCAE 3 grade within 4 weeks prior to enrollment.
* Arteriovenous thrombosis events occurred within 6 months.
* History of psychotropic substance abuse who are unable to quit or have a mental disorder.
* Participated in other anti-tumor clinical trials within 4 weeks.
* The investigator believes that there are any conditions that may damage the subject or result in the subject not being able to meet or perform the research request.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xing Zhang, professor

Conditions Soft Tissue Sarcoma