Actively Recruiting
Anlotinib Combined With Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Led by Guangdong Provincial People's Hospital · Updated on 2024-08-12
39
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of combining anlotinib with doxorubicin monotherapy and radiotherapy as a pre-surgery treatment for soft tissue sarcoma. This prospective, open-label, single-arm study focuses on patients with high-grade soft tissue sarcoma who are eligible for surgery and chemotherapy. The goal is to explore how this combined approach works before and after surgery. The treatment plan includes three cycles of neoadjuvant chemotherapy with doxorubicin given intravenously on days 1 and 2 every three weeks, alongside daily anlotinib for 14 days each cycle. After the second chemotherapy cycle, patients receive stereotactic body radiation therapy with a total dose of 40 Gy before surgery, which occurs in the ninth week following the third chemotherapy cycle. Post-surgery, patients continue with three additional cycles of chemotherapy, making six cycles in total. Participants will undergo regular assessments including pathological response evaluations at three months to measure major and complete responses. Researchers will also monitor objective tumor response and disease-free survival over two years. Safety and treatment adherence are tracked throughout the study. The total participation period includes chemotherapy cycles, radiotherapy, surgery, and follow-up assessments extending up to two years after treatment begins.
CONDITIONS
Brief Title
Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- ECOG Performance Status score of 0-1
- Histologically or cytologically confirmed diagnosis of high-grade soft tissue sarcoma (G2-G3) suitable for chemotherapy or radiotherapy
- Suitable for surgical resection after multidisciplinary assessment
- At least one measurable lesion per RECIST v1.1 and suitable for radiotherapy of 40 Gy or more
- Adequate hematology, pulmonary, renal, liver, and cardiac function
- Signed informed consent and good compliance
- Women of reproductive age must use reliable contraception or have a negative pregnancy test before enrollment and agree to contraception during the study and 8 weeks after the last drug dose
You will not qualify if you...
- Active or history of autoimmune disease
- Anti-tumor treatment within 4 weeks before enrollment, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- History or current other malignancies within 3 years, except certain cured cancers
- Unresectable sarcomas or cases where complete surgical removal is unsafe
- Conditions affecting oral medication intake
- Recent severe bleeding events within 4 weeks
- Uncontrolled diseases such as advanced heart failure, unstable angina, recent heart attack, active infections, HIV, psychiatric disorders, or substance abuse
- Blood clot or thromboembolic events within 6 months
- Heart failure Class III-IV or left ventricular ejection fraction below 50%
- Major surgery or severe injury within 4 weeks
- Long-standing unhealed wounds or fractures
- Pregnancy or breastfeeding
- Known allergy to study drugs
- Other factors judged by investigators that may lead to early withdrawal from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive 3 cycles of neoadjuvant chemotherapy with doxorubicin and anlotinib, combined with neoadjuvant radiotherapy starting after the second chemotherapy cycle before surgery.
3 chemotherapy cycles with radiotherapy starting after the second cycle
Duration - 1 day
Participants undergo radical resection surgery scheduled after the completion of the neoadjuvant chemotherapy and radiotherapy.
1 surgical procedure
Duration - Approximately 9 weeks
Participants receive 3 cycles of adjuvant chemotherapy with doxorubicin and anlotinib following surgery.
3 chemotherapy cycles
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
Guangdong provincial people's hospital
Guangzhou, Guangdong, China, 516008
Actively Recruiting
Research Team
Y
Yu Zhang, Ph.D.
Y
Yuan Yan, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here