Soft Tissue SarcomasPhase 4NCT04223583
Study on the Treatment of Soft Tissue Sarcoma With First-line Chemotherapy Failure by Anrotenil Hydrochloride Capsule
A Phase 4 study testing Anlotinib Hydrochloride in people with Soft Tissue Sarcomas, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Soft tissue sarcoma STS is a group of malignant tumors derived from connective tissue other than bone and cartilage. It can occur in any part of the body at any age, and there is no significant gender difference.According to pathological classification, STS has 19 tissue types and more than 50 disease… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcomas
- What is being tested?
- Anlotinib Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2019to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients volunteered to participate in this study and signed the informed consent;
- Pathologically confirmed advanced soft tissue sarcomas with at least one measurable lesionMainly including Synovial sarcoma (Synovial sarcoma), Leiomyosarcoma (Leiomyosarcoma), gland Alveolar soft tissue sarcoma (Alveolar soft part sarcoma), Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma), liposarcoma (AdipocyticEpithelial sarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, and other Tumors.Except for:Malignant peripheral nerve sheath tumor, Undifferentiated sarcoma, Rhabdomyosarcoma, chondrosarcoma, Osteosarcoma, dermato-fibrosarcomaProtuberans, gastrointestinal stromal tumor, Primitive neuroectodermal tumor, Inflammatory myofibroblastic tumor, Malignant mesothelioma.
- Patients who have failed treatment with at least one or two line chemotherapy regimen (doxorubicin + ifosfamide, gemcitabine + docetaxel) within the last 6 months (except for acinar soft tissue sarcoma);[note: treatment failure refers to the occurrence of disease progression or intolerance during treatment or within 3 months of the last treatment]
- 18 ~ 70 years old;ECOG PS score is 0~1;Expected survival beyond 3 months;
- Patients who are effective with other targeted drugs, but have drug resistance and disease progression, and stop taking drugs for more than 4 weeks;
- Major organ functions meet the following criteria within 7 days before treatment:
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- blood routine examination standard (in the condition of no blood transfusion within 14 days) :
- hemoglobin (HB) ≥90g/L;
- absolute value of neutrophils (ANC)≥1.5×109/L;
- platelet (PLT) ≥80×109/L
- biochemical examination shall meet the following standards:
- total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);
- alanine aminotransferase (ALT) and aspartate aminotransferase AST≤ 2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN;
- serum creatinine (Cr)≤1.5×ULN or creatinine clearance rate CCr≥60ml/min;
- doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- Women of childbearing age should agree that they must obtain a certain amount during the study period and within 6 months after the study Use contraceptives (such as intrauterine devices, birth control pills or condoms);Negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating;Men should agree to patients who must use contraception during the study period and within 6 months of the end of the study period.
Who cannot join
- Patients who have previously used anlotinib hydrochloride capsules;
- With pleural effusion or ascites, cause respiratory syndrome (≥CTC AE grade 2 dyspnea);
- Patients who have received targeted therapy of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, imatinib, bevacizumab, famitinib, apatinib, reagfenib and other drugs, have failed to respond to treatment.Other malignancies were present or present at the same time within 4.5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Systemic antitumor therapy, including cytotoxic therapy, immunotherapy, or mitomycin C, was planned for the first 4 weeks of the group or in this study.Radiotherapy was performed in the first 4 weeks or in the second 2 weeks before the grouping.
- Unrelieved toxic reactions above CTC AE(4.0) level 1 due to any previous treatment, excluding hair loss;
- Having multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);
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- Patients with brain metastasis with symptoms or symptom control time less than 2 months;
- Patients with any serious and/or uncontrolled illness, including:
- Patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
- Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc≥480ms) and grade ii or above congestive heart failure (New York heart association grade (NYHA));
- Active or uncontrolled severe infection (≥ grade CTC AE 2 infection);
- Patients with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis should receive antiviral treatment;
- Renal failure requires hemodialysis or peritoneal dialysis;
- Patients with any serious and/or uncontrolled illness, including:
- a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- poor diabetes control (FBG > 10mmol/L);
- the urine routine indicated that urine protein ≥++, and confirmed the 24-hour urine protein quantitative > 1.0g.
- patients with seizures requiring treatment;
- Significant surgical treatment, open biopsy or significant traumatic injury received within 28 days prior to grouping;
- Any physical signs or history of bleeding, regardless of severity;Unhealed wounds, ulcers or fractures were found in patients with any bleeding or bleeding event ≥CTCAE level 3 within 4 weeks before grouping;
- 6 months in the event of overactive/venous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
- Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
- Participated in clinical trials of other anti-tumor drugs within four weeks; According to the researchers' judgment, there are concomitant diseases that seriously endanger patients' safety or prevent patients from completing the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer Hospital
Zhengzhou, Henan
About this study
Soft tissue sarcoma STS is a group of malignant tumors derived from connective tissue other than bone and cartilage. It can occur in any part of the body at any age, and there is no significant gender difference.According to pathological classification, STS has 19 tissue types and more than 50 disease subtypes.Currently, surgical resection, radiotherapy and drug therapy are the main treatment methods.But about 50% of the patients with distant metastasis happened not the surgical removal of, quite a number of in patients with distant metastasis after died of disease progression 8-12 months in drug treatment of soft tissue sarcoma, the current widely used chemotherapy regimens for ADM/IFO single-agent or joint IFO ADM is a line of chemotherapy, in addition, paclitaxel, gemcitabine, dorsey race, it was also used for soft tissue sarcomas of second-line chemotherapy scheme, however, for some special subtypes of sarcoma,Such as myxoid liposarcoma, pleomorphic rhabdomyosarcoma, leiomyosarcoma, glandular soft tissue sarcoma and superficial malignant fibrous histiocytoma, are not sensitive to chemotherapy or low sensitivity.Therefore, how to improve the survival rate of these patients is an urgent problem to be solved.
Anlootinib hydrochloride is a multi-target tyrosine kinase inhibitor that has shown good efficacy in solid tumors such as NSCLC, ovarian cancer, soft tissue tumors, and medullary thyroid cancer.Especially in the field of soft tissue sarcomas, the results of phase IIb clinical data were satisfactory.Therefore, Investigator plan to conduct the study of anrotenil hydrochloride capsule for the treatment of soft tissue sarcomas with first-line chemotherapy failure (anthracycline)
- Conditions
- Soft Tissue Sarcomas
- Being tested
- Anlotinib Hydrochloride
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Also called Oral administration of single drug on an empty stomach
The standard first-line chemotherapy regimen (adriamycin + ifosfamide) failed
| Study group | Role | What they receive |
|---|---|---|
| Anrotenil hydrochloride capsule | Experimental | Anrotenil hydrochloride capsule was used to treat soft tissue sarcomas with first-line chemotherapy failure (doxorubicin + ifosfamide). Oral administration was conducted on an empty stomach before breakfast (12mg), and the drug was discontinued for 2 weeks for one week (3 weeks for one cycle) until the disease progressed or became intolerable. Receives: Drug: Anlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median progression-free survival（mPFS）
There are and only 50% of individuals who survive this time
Measured: up to 12 months
Secondary outcomes (1)
Objective response rate（ORR)
The percentage of patients whose tumors have shrunk to a certain amount of time and stayed that way for a certain amount of time
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 posted10 Jan 2020
- Study start26 Jun 2019
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, YaoWeitao, Henan Cancer Hospital
- Investigators
- Peng Zhang, Deputy director, Study chair, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223583
- Sponsor's protocol ID
- 2019212
- Status last verified
- Mar 2022
- First submitted
- 26 Sep 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to better conduct clinical studies and ensure the prospective and timeliness of the studies, patients' IPD will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Treatment of Soft Tissue Sarcoma With First-line Chemotherapy Failure by Anrotenil Hydrochloride Capsule
- ClinicalTrials.gov ID
- NCT04223583
- Acronym / sponsor ID
- 2019212
- Conditions
- Soft Tissue Sarcomas
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 10 Jan 2020 (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.
Soft tissue sarcoma STS is a group of malignant tumors derived from connective tissue other than bone and cartilage. It can occur in any part of the body at any age, and there is no significant gender difference.According to pathological classification, STS has 19 tissue types and more than 50 disease subtypes.Currently, surgical resection, radiotherapy and drug therapy are the main treatment methods.But about 50% of the patients with distant metastasis happened not the surgical removal of, quite a number of in patients with distant metastasis after died of disease progression 8-12 months in drug treatment of soft tissue sarcoma, the current widely used chemotherapy regimens for ADM/IFO single-agent or joint IFO ADM is a line of chemotherapy, in addition, paclitaxel, gemcitabine, dorsey race, it was also used for soft tissue sarcomas of second-line chemotherapy scheme, however, for some special subtypes of sarcoma,Such as myxoid liposarcoma, pleomorphic rhabdomyosarcoma, leiomyosarcoma, glandular soft tissue sarcoma and superficial malignant fibrous histiocytoma, are not sensitive to chemotherapy or low sensitivity.Therefore, how to improve the survival rate of these patients is an urgent problem to be solved.
Anlootinib hydrochloride is a multi-target tyrosine kinase inhibitor that has shown good efficacy in solid tumors such as NSCLC, ovarian cancer, soft tissue tumors, and medullary thyroid cancer.Especially in the field of soft tissue sarcomas, the results of phase IIb clinical data were satisfactory.Therefore, Investigator plan to conduct the study of anrotenil hydrochloride capsule for the treatment of soft tissue sarcomas with first-line chemotherapy failure (anthracycline)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anrotenil hydrochloride capsule | Experimental | Drug: Anlotinib HydrochlorideAnrotenil hydrochloride capsule was used to treat soft tissue sarcomas with first-line chemotherapy failure (doxorubicin + ifosfamide). Oral administration was conducted on an empty stomach before breakfast (12mg), and the drug was discontinued for 2 weeks for one week (3 weeks for one cycle) until the disease progressed or became intolerable. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The patients volunteered to participate in this study and signed the informed consent;
- Pathologically confirmed advanced soft tissue sarcomas with at least one measurable lesionMainly including Synovial sarcoma (Synovial sarcoma), Leiomyosarcoma (Leiomyosarcoma), gland Alveolar soft tissue sarcoma (Alveolar soft part sarcoma), Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma), liposarcoma (AdipocyticEpithelial sarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, and other Tumors.Except for:Malignant peripheral nerve sheath tumor, Undifferentiated sarcoma, Rhabdomyosarcoma, chondrosarcoma, Osteosarcoma, dermato-fibrosarcomaProtuberans, gastrointestinal stromal tumor, Primitive neuroectodermal tumor, Inflammatory myofibroblastic tumor, Malignant mesothelioma.
- Patients who have failed treatment with at least one or two line chemotherapy regimen (doxorubicin + ifosfamide, gemcitabine + docetaxel) within the last 6 months (except for acinar soft tissue sarcoma);[note: treatment failure refers to the occurrence of disease progression or intolerance during treatment or within 3 months of the last treatment]
- 18 ~ 70 years old;ECOG PS score is 0~1;Expected survival beyond 3 months;
- Patients who are effective with other targeted drugs, but have drug resistance and disease progression, and stop taking drugs for more than 4 weeks;
Key exclusion criteria (23 listed)
- Patients who have previously used anlotinib hydrochloride capsules;
- With pleural effusion or ascites, cause respiratory syndrome (≥CTC AE grade 2 dyspnea);
- Patients who have received targeted therapy of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, imatinib, bevacizumab, famitinib, apatinib, reagfenib and other drugs, have failed to respond to treatment.Other malignancies were present or present at the same time within 4.5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Systemic antitumor therapy, including cytotoxic therapy, immunotherapy, or mitomycin C, was planned for the first 4 weeks of the group or in this study.Radiotherapy was performed in the first 4 weeks or in the second 2 weeks before the grouping.
- Unrelieved toxic reactions above CTC AE(4.0) level 1 due to any previous treatment, excluding hair loss;
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 |
|---|---|---|
| Anlotinib HydrochlorideAlso: Oral administration of single drug on an empty stomachThe standard first-line chemotherapy regimen (adriamycin + ifosfamide) failed | Drug | Anrotenil hydrochloride capsule |
Primary outcome
Median progression-free survival（mPFS）
Time frame: up to 12 months
There are and only 50% of individuals who survive this time
1 secondary outcome
Objective response rate（ORR)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No. In order to better conduct clinical studies and ensure the prospective and timeliness of the studies, patients' IPD will be kept confidential.
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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. This study is not recruiting at the moment.
Peng Zhang, Deputy director study chair
Henan Cancer Hospital
1 site 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 Hydrochloride in people with Soft Tissue Sarcomas, run by Henan Cancer Hospital at 1 site 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 16 inclusion and 23 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: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression-free survival（mPFS） (time frame: up to 12 months). 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 16 Mar 2022.