Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS) (NCT03016819)
A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma
🩺 Plain-English Summary (8th-Grade Level)
THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA. This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Mayo Clinic Arizona — Phoenix, Arizona
- University of California Los Angeles — Los Angeles, California
- Sarcoma Oncology Center — Santa Monica, California
- Stanford Medicine Cancer Institute — Stanford, California
- University of Colorado Denver — Aurora, Colorado
- Mayo Clinic Jacksonville — Jacksonville, Florida
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
- Northwestern University — Chicago, Illinois
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan
- Mayo Clinic Rochester — Rochester, Minnesota
- Washington University St. Louis — St Louis, Missouri
- Columbia University Medical Center — New York, New York
- Thomas Jefferson Hospital - Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Vanderbilt University — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- UW Medicine-Seattle Cancer Care Alliance — Seattle, Washington
- Beijing Cancer Hospital — Beijing,
- Shanghai Sixth People's Hospital — Shanghai,
- Istituto Nazionale dei Tumori — Milan,
- University of Palermo — Palermo,
- University Campus Bio-Medico — Rome,
- Hospital de la Santa Creu i Sant Pau — Barcelona,
- Royal Marsden Hospital — London,
📞 Contact the Study Coordinator
Phone: (805) 530-1550
Email: Shiyings@advenchen.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.