Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft PartSarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
Trial ID: NCT03016819
Phase: Phase 3
Status: Active but not recruiting, (Synovial Sarcoma cohort closed)
Last Update Posted: February 2026
Please Note: The synovial sarcoma cohort of this trial is closed to new enrollment. This trial is currently only recruiting patients with alveolar soft part sarcoma.
Eligibility: Adults aged 18 and older with advanced solid tumors, including synovial sarcoma, whose tumors express the NY-ESO-1 antigen and are HLA-A*02 positive. The synovial sarcoma portion of this trial is no longer recruiting new participants.
Overview: This Phase 3 trial evaluated AL3818 (anlotinib/catequentinib), an oral multikinase inhibitor, in patients with advanced alveolar soft part sarcoma, leiomyosarcoma, and synovial sarcoma. For synovial sarcoma patients, the study compared anlotinib against IV dacarbazine in a 2:1 randomization. Participants with synovial sarcoma were required to have previously received at least one line of standard therapy including first-line anthracycline chemotherapy. The synovial sarcoma cohort has since closed, and the study currently continues only for alveolar soft part sarcoma patients.
Preliminary Effectiveness: Early studies of NY-ESO-1 directed T-cell therapies have shown promising anti-tumor responses in synovial sarcoma, helping pave the way for newer T-cell therapies currently being tested in clinical trials. No formal results for the synovial sarcoma cohort have been posted to ClinicalTrials.gov at this time.

Study Contact: Advenchen Laboratories, LLC

Treatment Centers: USA, China, Italy, Spain, UK

More Information: clinicaltrials.gov/study/NCT03016819