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

NCT06506838 | Recruiting Phase 4 DMC

• 1 other identifier: AnlotinibSTS
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Soft Tissue Sarcoma; Doxorubicin; Radiotherapy

Keywords

Soft Tissue Sarcoma; doxorubicin; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Major Pathological Response rate

  Typically defined as residual tumor cells ≤10% in the surgical specimen after treatment

  3 months

• Pathologic Complete Response rate

  Absence of any residual tumor cells in the surgical specimen following treatment.

  3 months

Secondary Outcomes (2)

• Objective Response Rate

  3 months

• Disease-Free Survival

  2 years

Study Arms (1)

Intervention Group

EXPERIMENTAL

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.

Drug: Anlotinib

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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%.
• Signed informed consent and good compliance.
• 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.

You may not qualify if:

• 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.
• Factors affecting oral medication (such as dysphagia, severe chronic diarrhea, and intestinal obstruction, etc.).
• History of bleeding, with any grade 3 or higher bleeding event as per CTCAE 4.0 within 4 weeks before screening.
• 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.
• According to NYHA standards, Class III-IV heart failure, or left ventricular ejection fraction (LVEF) \<50% on echocardiography.
• Major surgery within 4 weeks prior to randomization or severe traumatic injury, fracture, or ulcer.
• Long-standing unhealed wounds or fractures.
• Pregnancy or lactation in women.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Guangdong provincial people's hospital

Guangzhou, Guangdong, 516008, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yu Zhang, Ph.D.

CONTACT

8613602744495; luck_2001@126.com

Yuan Yan, Ph.D.

CONTACT

8613178504143; Yuan_Yan2021@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2028
• Last Updated: August 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)