A Prospective, Open-Label, Single-Arm Clinical Study of Anlotinib Combined With Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 years.

• ECOG Performance Status score of 0-1.

• Histologically or cytologically confirmed diagnosis of high-grade soft tissue sarcoma (G2-G3), classified as moderately sensitive or higher to chemotherapy (or determined suitable for radiotherapy and chemotherapy by the investigator). Typically includes histological types such as synovial sarcoma, vascular sarcoma, adult fibrosarcoma, intramuscular chondrosarcoma, leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, hepatic undifferentiated embryonic sarcoma, and unclassified soft tissue sarcomas.

• Clinical confirmation of soft tissue sarcoma suitable for surgical resection after multidisciplinary assessment.

• Presence of at least one measurable lesion according to RECIST v1.1 assessment criteria and suitable for ≥40 Gy/f radiotherapy (or determined suitable for radiotherapy by the investigator).

• Laboratory and other examinations:Hematology: Absolute neutrophil count ≥1500/μL, platelet count ≥100,000/μL. Pulmonary function: No respiratory difficulty at rest, no reduced exercise tolerance, resting pulse oximetry \>94% in room air.

• Renal function (creatinine clearance or radioisotope GFR ≥70 mL/min/1.73 m² or serum creatinine within normal limits according to age/gender). Liver function (total bilirubin ≤1.5 × ULN, AST or ALT \<2.5 × ULN). Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%.

• Signed informed consent and good compliance.

• Reproductive-age women must use reliable contraception or have a negative pregnancy test (serum or urine) within 7 days before enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last dose of investigational drug.

Locations
Other Locations
China
Guangdong provincial people's hospital
RECRUITING
Guangzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Yu Zhang, Ph.D.
luck_2001@126.com
8613602744495
Backup
Yuan Yan, Ph.D.
Yuan_Yan2021@163.com
8613178504143
Time Frame
Start Date: 2024-08-10
Estimated Completion Date: 2028-07-20
Participants
Target number of participants: 39
Treatments
Experimental: Intervention Group
For patients with the soft tissue sarcoma, the treatment regimen includes doxorubicin monotherapy with neoadjuvant and adjuvant chemotherapy cycles, alongside anlotinib and stereotactic body radiation therapy before surgery, followed by radical resection.
Related Therapeutic Areas
Sponsors
Leads: Guangdong Provincial People's Hospital

This content was sourced from clinicaltrials.gov