Trial Title:
Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
NCT ID:
NCT06506838
Condition:
Soft Tissue Sarcoma
Doxorubicin
Radiotherapy
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
Soft Tissue Sarcoma
doxorubicin
Radiotherapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib
Description:
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.
Arm group label:
Intervention Group
Summary:
Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and
Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years.
2. ECOG Performance Status score of 0-1.
3. 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.
4. Clinical confirmation of soft tissue sarcoma suitable for surgical resection after
multidisciplinary assessment.
5. 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).
6. 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%.
7. Signed informed consent and good compliance.
8. 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.
Exclusion Criteria:
1. Active autoimmune disease or history of autoimmune disease.
2. 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.
3. 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)].
4. Unresectable sarcomas, including severe vascular, neural, or bone involvement, or
cases where complete surgical resection is not safely feasible.
5. Factors affecting oral medication (such as dysphagia, severe chronic diarrhea, and
intestinal obstruction, etc.).
6. History of bleeding, with any grade 3 or higher bleeding event as per CTCAE 4.0
within 4 weeks before screening.
7. Uncontrolled diseases or past medical history, such as:
- NYHA Class ≥2 heart failure, unstable angina, myocardial infarction within the
past 12 months.
- Active infections requiring systemic treatment.
- Known HIV infection, syphilis history, psychiatric disorders (such as epilepsy
and dementia), or substance abuse disorders.
- Thromboembolic events (including transient ischemic attacks, cerebral
hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism
within the past 6 months before enrollment.
8. According to NYHA standards, Class III-IV heart failure, or left ventricular
ejection fraction (LVEF) <50% on echocardiography.
9. Major surgery within 4 weeks prior to randomization or severe traumatic injury,
fracture, or ulcer.
10. Long-standing unhealed wounds or fractures.
11. Pregnancy or lactation in women.
12. Known allergy to any investigational drug.
13. Investigator judgment that the subject has other factors that may lead to premature
termination of the study, such as severe laboratory abnormalities, family or social
factors affecting subject safety, or data and sample collection.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zhang, M.D.
Email:
luck_2001@126.com
Contact backup:
Last name:
Yuan Yan, Ph.D.
Phone:
13178504143
Email:
yanyuanisgood@qq.com
Facility:
Name:
Guangdong provincial people's hospital
Address:
City:
Guangzhou
Zip:
516008
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoqing Zhong, M.D.
Email:
gqzhong@foxmail.com
Start date:
August 10, 2024
Completion date:
July 20, 2028
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06506838
