Actively Recruiting
Anlotinib Combined With Doxorubicin 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
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
CONDITIONS
Official 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 between 18 and 75 years
- ECOG Performance Status score of 0 or 1
- Histologically or cytologically confirmed high-grade soft tissue sarcoma (G2-G3), moderately sensitive or higher to chemotherapy or suitable for radiotherapy and chemotherapy
- Soft tissue sarcoma clinically suitable for surgical resection after multidisciplinary assessment
- At least one measurable lesion per RECIST v1.1 criteria, suitable for radiotherapy with a dose of ≥40 Gy/fraction
- Adequate hematology: absolute neutrophil count ≥1500/µL, platelet count ≥100,000/µL
- No respiratory difficulty at rest, no reduced exercise tolerance, resting pulse oximetry >94% in room air
- Adequate renal function: creatinine clearance or radioisotope GFR ≥70 mL/min/1.73 m² or normal serum creatinine for age/gender
- Adequate liver function: total bilirubin ≤1.5 × ULN, AST or ALT <2.5 × ULN
- Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥50%
- Signed informed consent and good compliance
- Women of reproductive age must use reliable contraception or have a negative pregnancy test within 7 days before enrollment and agree to contraception during study and 8 weeks after last dose
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease
- Any anti-tumor treatment within 4 weeks prior to enrollment, including radiotherapy, chemotherapy, molecular targeted therapy, or immunotherapy (except if last anti-tumor drug stopped ≥5 half-lives before enrollment)
- Participation in another interventional clinical trial
- History or current malignancy within 3 years except certain cured cancers
- Unresectable sarcomas or cases where complete surgical resection is unsafe
- Conditions affecting oral medication intake such as dysphagia, severe chronic diarrhea, or intestinal obstruction
- History of grade 3 or higher bleeding events within 4 weeks before screening
- Uncontrolled diseases or past medical history including NYHA Class ≥2 heart failure, recent myocardial infarction, active infections requiring systemic treatment, known HIV infection, psychiatric disorders, or substance abuse
- Thromboembolic events within 6 months before enrollment
- NYHA Class III-IV heart failure or LVEF <50%
- Major surgery within 4 weeks before randomization or severe traumatic injury, fracture, or ulcer
- Long-standing unhealed wounds or fractures
- Pregnancy or breastfeeding
- Known allergy to any investigational drug
- Other factors that may lead to early study termination such as severe lab abnormalities or social factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
Y
Yuan Yan, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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