Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital
About this trial
Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active autoimmune disease or history of autoimmune disease.
Receipt of any form of anti-tumor treatment within 4 weeks prior to enrollment, including radiotherapy, chemotherapy, molecular targeted therapy (such as angiogenesis inhibitors like sunitinib, sorafenib, imatinib, famitinib, regorafenib), and immunotherapy (eligible if last anti-tumor drug was stopped ≥5 half-lives before enrollment), or participation in another interventional clinical trial.
History of or current simultaneous malignancy within 3 years, excluding cured lung cancer, cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)].
Unresectable sarcomas, including severe vascular, neural, or bone involvement, or cases where complete surgical resection is not safely feasible.
Trial design
Design model
Single group
Treatments tested in this trial
Anlotinib
DrugFor 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.
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Pathological Response rate
Typically defined as residual tumor cells ≤10% in the surgical specimen after treatment
Time frame
3 months2
Pathologic Complete Response rate
Absence of any residual tumor cells in the surgical specimen following treatment.
Time frame
3 monthsSecondary outcomes
1
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 months2
Disease-Free Survival
The length of time during and after treatment that a patient lives with the disease without it progressing
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov