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

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT06506838
Phase
PHASE4
Status
Recruiting
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Conditions

  • Doxorubicin
  • Radiotherapy
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib — DRUG
    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.

Study Details

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

Key Dates

First listed
Jul 18, 2024
Start date
Aug 10, 2024
Status verified
Jul 2024
Primary completion
Jul 20, 2027
Completion
Jul 20, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Major Pathological Response rate [ Time Frame: 3 months ]

Central Contacts

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