Soft Tissue SarcomaPhase 3NCT05121350
A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
A Phase 3 study testing Anlotinib hydrochloride capsule and Epirubicin in people with Soft Tissue Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
Trial summary
A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced 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
- What is being tested?
- Anlotinib hydrochloride capsule and Epirubicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2022to Jun 2024
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy >=3 months.
- Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
- Understood and signed an informed consent form.
Who cannot join
- Diagnosed and/or treated additional malignancy within 5 years before the first dose.
- With factors affecting oral medication.
- Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.
- A history of psychotropic drug abuse or have a mental disorder.
- Any severe and/or uncontrolled diseas.
- Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose.
- Has participated in other clinical studies within 4 weeks before the first dose.
- According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100032
Xiaohui Niu, Bachelor, 13801132522, moonlight003@163.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Wei Guo, Doctor, 13701195504, bonetumor@163.com
- Recruiting
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
YUHONG ZHOU, Doctor, 13918286810, Zhou.yuhong@zs-hospital.sh.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Anlotinib hydrochloride capsule, Epirubicin, Arotinib hydrochloride capsule placebo
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride capsuleDrug
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
EpirubicinDrug
Epirubicin can inhibit the synthesis of DNA and RNA.
Arotinib hydrochloride capsule placeboDrug
Placebo of Anlotinib hydrochloride capsule
| Study group | Role | What they receive |
|---|---|---|
| Arotinib hydrochloride capsule + Epirubicin | Experimental | Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle Receives: Drug: Anlotinib hydrochloride capsule; Drug: Epirubicin |
| Placebo + Epirubicin | Active comparator | Placebo combined with epirubicin, 21 days as a treatment cycle Receives: Drug: Epirubicin; Drug: Arotinib hydrochloride capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) assessed by independent review committees (IRC)
Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first
Measured: Baseline up to 12 months
Secondary outcomes (6)
Overall survival (OS)
From randomization to the time of death from any cause
Measured: Baseline up to die
progression free survival (PFS) assessed by investigator
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
Measured: Baseline up to 12 months
Objective response rate (ORR)
The sum of percentage of participants with complete response rate and partial response rate
Measured: Baseline up to 6 months
Disease control rate (DCR)
percentage of participants with complete response, partial response plus stable disease
Measured: Baseline up to 25 months
Duration of overall response (DOR)
the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression
Measured: Baseline up to 6 months
Degradation rate
Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study startMar 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121350
- Sponsor's protocol ID
- ALTN-III-04
- Status last verified
- Feb 2022
- First submitted
- 15 Nov 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT05121350
- Acronym / sponsor ID
- ALTN-III-04
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Nov 2021 (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.
A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arotinib hydrochloride capsule + Epirubicin | Experimental | Drug: Anlotinib hydrochloride capsule, Drug: EpirubicinArotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle |
| Placebo + Epirubicin | Active comparator | Drug: Epirubicin, Drug: Arotinib hydrochloride capsule placeboPlacebo combined with epirubicin, 21 days as a treatment cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy >=3 months.
- Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
- Understood and signed an informed consent form.
Key exclusion criteria (8 listed)
- Diagnosed and/or treated additional malignancy within 5 years before the first dose.
- With factors affecting oral medication.
- Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.
- A history of psychotropic drug abuse or have a mental disorder.
- Any severe and/or uncontrolled diseas.
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 hydrochloride capsuleAnlotinib hydrochloride is a multi-target tyrosine kinase inhibitor. | Drug | Arotinib hydrochloride capsule + Epirubicin |
| EpirubicinEpirubicin can inhibit the synthesis of DNA and RNA. | Drug | Arotinib hydrochloride capsule + Epirubicin, Placebo + Epirubicin |
| Arotinib hydrochloride capsule placeboPlacebo of Anlotinib hydrochloride capsule | Drug | Placebo + Epirubicin |
Primary outcome
Progression free survival (PFS) assessed by independent review committees (IRC)
Time frame: Baseline up to 12 months
Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first
6 secondary outcomes
Overall survival (OS)
Time frame: Baseline up to die
progression free survival (PFS) assessed by investigator
Time frame: Baseline up to 12 months
Objective response rate (ORR)
Time frame: Baseline up to 6 months
Disease control rate (DCR)
Time frame: Baseline up to 25 months
Duration of overall response (DOR)
Time frame: Baseline up to 6 months
Degradation rate
Time frame: Baseline up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib hydrochloride capsule and Epirubicin in people with Soft Tissue Sarcoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanghai Niu, Bachelor (13801132522, moonlight003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) assessed by independent review committees (IRC) (time frame: Baseline 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 18 Feb 2022.