Soft Tissue SarcomaPhase 4NCT06506838
Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
A Phase 4 study testing Anlotinib in people with Soft Tissue Sarcoma and Doxorubicin, run by Guangdong Provincial People's Hospital at 2 sites in China.
Trial summary
Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Soft Tissue Sarcoma, Doxorubicin, Radiotherapy
- What is being tested?
- Anlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2024to 20 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Known allergy to any investigational drug.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yu Zhang, M.D., luck_2001@126.com
Yuan Yan, Ph.D., 13178504143, yanyuanisgood@qq.com
- Recruiting
Guangdong provincial people's hospital
Guangzhou, Guangdong, 516008
Guoqing Zhong, M.D., gqzhong@foxmail.com
About this study
Official title: A Prospective, Open-Label, Single-Arm Clinical Study of Anlotinib Combined With Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
Read the 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.
- Conditions
- Soft Tissue Sarcoma, Doxorubicin, Radiotherapy
- Being tested
- Anlotinib
- Keywords
- Soft Tissue Sarcoma, doxorubicin, Radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response rate
Typically defined as residual tumor cells ≤10% in the surgical specimen after treatment
Measured: 3 months
Pathologic Complete Response rate
Absence of any residual tumor cells in the surgical specimen following treatment.
Measured: 3 months
Secondary outcomes (2)
Objective Response Rate
The proportion of patients in a clinical trial whose tumor size decreases (partial response) or disappears (complete response) after treatment.
Measured: 3 months
Disease-Free Survival
The length of time during and after treatment that a patient lives with the disease without it progressing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Aug 2024 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506838
- Sponsor's protocol ID
- AnlotinibSTS
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Clinical Study of Anlotinib Combined With Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT06506838
- Acronym / sponsor ID
- AnlotinibSTS
- Conditions
- Soft Tissue Sarcoma, Doxorubicin, Radiotherapy
- Keywords
- Soft Tissue Sarcoma, doxorubicin, Radiotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2028 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: AnlotinibFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnlotinibFor 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. | Drug | Intervention Group |
Primary outcome
Major Pathological Response rate
Time frame: 3 months
Typically defined as residual tumor cells ≤10% in the surgical specimen after treatment
Pathologic Complete Response rate
Time frame: 3 months
Absence of any residual tumor cells in the surgical specimen following treatment.
2 secondary outcomes
Objective Response Rate
Time frame: 3 months
Disease-Free Survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anlotinib in people with Soft Tissue Sarcoma and Doxorubicin, run by Guangdong Provincial People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, Ph.D. (8613602744495, luck_2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.