Actively Recruiting
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
Led by Advenchen Laboratories, LLC · Updated on 2026-02-25
325
Participants Needed
24
Research Sites
589 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and able to understand the study
- Male or female aged 18 years or older
- Histologically confirmed unresectable, locally advanced or metastatic alveolar soft part sarcoma (ASPS)
- For ASPS, subjects may have had prior therapy or not
- Show clinical or objective disease progression within 6 months after last standard therapy or stopped due to intolerance (excluding untreated ASPS subjects)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have measurable disease by RECIST version 1.1 confirmed by CT or MRI within 28 days before enrollment
- Life expectancy of at least 3 months
- Females of childbearing potential must have a negative pregnancy test within 7 days before treatment start
- Females of childbearing potential must be surgically sterile, abstinent, or agree to use contraception until 3 months after last study drug
- Males must agree to use adequate contraception until 3 months after last study drug
- Adequate blood, liver, and kidney function within 28 days before enrollment
- Left ventricular ejection fraction greater than 50% by ECHO or MUGA within 56 days before enrollment
- Stable blood pressure with systolic <140 mm Hg and diastolic <90 mm Hg at screening
You will not qualify if you...
- Prior treatment with or known allergy to AL3818
- Prior treatment with cediranib for ASPS
- Prior treatment with or known allergy to dacarbazine for LMS or SS
- Prior treatment with anlotinib for LMS in indication D
- Previous or concurrent cancer different from ASPS, LMS, or SS within 5 years except some treated cancers
- Received systemic cytotoxic therapy within 21 days or other anti-cancer therapies within 14 days before enrollment
- Prior extended-field radiotherapy within 28 days or other radiotherapy within 14 days before enrollment
- Active central nervous system metastases or carcinomatous meningitis unless stable
- Tumors invading large thoracic blood vessels or cavitary tumors
- Recent history (within 6 months) of gastrointestinal perforation, fistula, or abscess
- Known bleeding disorders or recent significant bleeding
- Untreated deep venous thrombosis within past 6 months
- Use of high-dose aspirin within 10 days before treatment
- Serious non-healing wounds or active ulcers
- Recent major surgery or significant injury within 28 days or minor surgery within 7 days before enrollment
- Severe peripheral neuropathy or unrecovered toxicities from previous therapy
- QTcF interval over 470 msec on ECG within 28 days before enrollment
- Severe uncontrolled medical conditions including heart, liver, kidney, infections, diabetes, seizures, psychiatric disorders
- Known HIV positive status
- History of organ transplantation
- Conditions preventing oral medication intake
- Pregnant or breastfeeding females
- Use of strong enzyme inhibitors or inducers affecting study drugs within 14 days before enrollment
- Any other condition that could affect study adherence or objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Completed
2
University of California Los Angeles
Los Angeles, California, United States, 90404
Completed
3
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
4
Stanford Medicine Cancer Institute
Stanford, California, United States, 94305
Completed
5
University of Colorado Denver
Aurora, Colorado, United States, 80045
Completed
6
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Completed
7
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Completed
8
Northwestern University
Chicago, Illinois, United States, 60611
Completed
9
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Completed
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Completed
11
Washington University St. Louis
St Louis, Missouri, United States, 63130
Completed
12
Columbia University Medical Center
New York, New York, United States, 10032
Withdrawn
13
Thomas Jefferson Hospital - Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Completed
14
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Completed
15
Vanderbilt University
Nashville, Tennessee, United States, 37203
Completed
16
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
17
UW Medicine-Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Completed
18
Beijing Cancer Hospital
Beijing, China
Completed
19
Shanghai Sixth People's Hospital
Shanghai, China
Completed
20
Istituto Nazionale dei Tumori
Milan, Italy
Completed
21
University of Palermo
Palermo, Italy
Completed
22
University Campus Bio-Medico
Rome, Italy
Completed
23
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Completed
24
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
Research Team
S
Shiying Clinical Trial Manager
CONTACT
J
Judy Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
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