RecruitingPhase 4NCT06506838

Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

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


Sponsor

Guangdong Provincial People's Hospital

Enrollment

39 participants

Start Date

Aug 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of anlotinib (a targeted anti-cancer drug), doxorubicin (chemotherapy), and radiation therapy as a pre-surgery (neoadjuvant) treatment for patients with high-grade soft tissue sarcoma — aggressive cancers of the body's connective tissues like muscle, fat, or vessels. The goal is to shrink tumors before surgery. **You may be eligible if...** - You are 18–75 years old with histologically confirmed high-grade soft tissue sarcoma (Grade 2–3) - Your sarcoma is a type that responds to chemotherapy (e.g., synovial sarcoma, leiomyosarcoma, liposarcoma) - Your cancer can potentially be surgically removed after treatment - You have at least one measurable lesion and are fit for radiation - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your sarcoma type does not respond to the planned treatments - You cannot tolerate surgery, radiation, or chemotherapy - You have another concurrent cancer - You are pregnant or breastfeeding - Your organ function is inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib

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.


Locations(2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

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NCT06506838


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