Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
This is a a prospective, open-Label, and single-arm clinical study. This study aims to evaluate the efficacy and safety of using anlotinib in combination with doxorubicin monotherapy and radiotherapy as a neoadjuvant treatment for soft tissue sarcoma. For patients with the soft tissue sarcoma, the standard doxorubicin monotherapy regimen involves administering 37.5 mg/m² intravenously on days 1-2 of each 3-week cycle. The treatment includes 3 cycles of neoadjuvant chemotherapy (pre-surgery) and 3 cycles of adjuvant chemotherapy (post-surgery), totaling 6 cycles. Anlotinib (ALC) is administered at 12mg/d QD,day1\~14, 21d/cycle. Neoadjuvant radiotherapy is conducted before surgery, starting after the second chemotherapy cycle, using stereotactic body radiation therapy (SBRT) with a dose of 4\*10 Gy. Radical resection surgery is performed in the ninth week, after the third chemotherapy cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
For patients with the soft tissue sarcoma, the standard doxorubicin monotherapy regimen involves administering 37.5 mg/m² intravenously on days 1-2 of every 3 week . The treatment includes 3 cycles of neoadjuvant chemotherapy before surgery and 3 cycles of adjuvant chemotherapy after surgery, totaling 6 cycles. Anlotinib is administered at 12mg/d QD,day1\~14, 21d/cycle. Neoadjuvant radiotherapy is conducted before surgery, starting after the second chemotherapy cycle, using stereotactic body radiation therapy (SBRT) with a dose of 4\*10 Gy. Radical resection surgery is performed after the third chemotherapy cycle.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGGuangdong provincial people's hospital
Guangzhou, Guangdong, China
RECRUITINGMajor Pathological Response rate
Typically defined as residual tumor cells ≤10% in the surgical specimen after treatment
Time frame: 3 months
Pathologic Complete Response rate
Absence of any residual tumor cells in the surgical specimen following treatment.
Time frame: 3 months
Objective Response Rate
The proportion of patients in a clinical trial whose tumor size decreases (partial response) or disappears (complete response) after treatment.
Time frame: 3 months
Disease-Free Survival
The length of time during and after treatment that a patient lives with the disease without it progressing
Time frame: 2 years
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