Stage III Adult Soft Tissue SarcomaPhase 2NCT04765228
Pegylated Liposomal Doxorubicin Combined With Anlotinib for Neoadjuvant Treatment of Soft Tissue Sarcoma
A Phase 2 study testing Pegylated liposomal doxorubicin and Anlotinib in people with Stage III Adult Soft Tissue Sarcoma, run by Yong Chen at 1 site in China.
Trial summary
A prospective one-arm study of pegylated liposomal doxorubicin combined with anlotinib for neoadjuvant treatment of locally advanced soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Stage III Adult Soft Tissue Sarcoma
- What is being tested?
- Pegylated liposomal doxorubicin and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 2022
- Phase
- Phase 2
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with soft tissue sarcoma confirmed by histopathology;
- Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCC staging of soft tissue sarcoma, or tumors that are closely related to important blood vessels and important nerves suggested by imaging data;
- No distant transfer
- According to the preliminary judgment of the research, patients who can improve the effect of surgery by neoadjuvant treatment;
- Male or female, aged ≥14 years old and ≤75 years old;
- ECOG score ≤ 2;
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- The expected survival period is ≥3 months;
- Adequate hematopoietic function: absolute neutrophil count (ANC) ≥ 1.5×109/L and platelet count ≥ 80×109/L and hemoglobin ≥ 9 g/dL;
- Sufficient liver function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 1.5 times the upper limit of normal (ULN); alkaline phosphatase ≤ 5 times the upper limit of normal (ULN);
- Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min;
- Visceral function: LVEF≥50%, the New York Society of Visceral Disease Association (NYHA) has a functional classification of I and II, and there is no unhealed wound on the body;
- Sign the informed consent form.
- Women should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy within 7 days before study entry The test is negative and must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
- The patient voluntarily joined the study, signed an informed consent form, had good compliance, and was able to be followed up by the trial staff.
Who cannot join
- Ewing's sarcoma, embryonic rhabdomyosarcoma, acinar rhabdomyosarcoma
- Pregnant or breastfeeding women, or women who are fertile but have not taken contraceptive measures
- Existing severe acute infection that has not been controlled; or having purulent or chronic infection, and the wound is protracted
- Active hepatitis B or C
- Have a history of other tumors within 5 years before treatment, except for cured cervical carcinoma in situ or skin basal cell carcinoma
- Those who have participated in other drug clinical trials within 4 weeks
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- Patients with pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and refractory hypertension, ventricular tachycardia, ventricular, Patients with atrial fibrillation, second-degree type II or third-degree atrioventricular block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease requiring medication
- People with uncontrollable neurological or mental diseases or mental disorders, poor compliance, unable to cooperate and describe the treatment response; primary brain tumors or central nerve metastases have not been controlled, and have obvious intracranial hypertension or neuropsychiatry Symptoms
- Past severe chronic skin diseases
- People with bleeding tendency, evidence of hereditary bleeding constitution or coagulopathy
- Have a clear history of allergy to chemotherapy drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Chen C Yong, M.D., 13917530417, chenyong@fudan.edu.cn
Yong Chen, M.D.
About this study
Official title: A Prospective One-arm Study of Pegylated Liposomal Doxorubicin Combined With Anlotinib for Neoadjuvant Treatment of Locally Advanced Soft Tissue Sarcoma
A prospective one-arm study of pegylated liposomal doxorubicin combined with anlotinib for neoadjuvant treatment of locally advanced soft tissue sarcoma.
Read the detailed description
Tumor angiogenesis is very important in the occurrence and development of soft tissue sarcoma. The current clinical studies of molecularly targeted drugs are focused on the advanced treatment stage of soft tissue sarcoma. Anti-angiogenic drugs are not yet available in the neoadjuvant treatment stage of soft tissue sarcoma. Strong evidence. Therefore, this study aimed to evaluate the safety and effectiveness of pegylated doxorubicin liposomes combined with the anti-angiogenic drug Anlotinib for neoadjuvant treatment of patients with soft tissue sarcoma.
- Conditions
- Stage III Adult Soft Tissue Sarcoma
- Being tested
- Pegylated liposomal doxorubicin, Anlotinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
Pegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2~4 cycles
AnlotinibDrug
Anlotinib
| Study group | Role | What they receive |
|---|---|---|
| Pegylated liposomal doxorubicin + Anlotinib | Experimental | Pegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2~4 cycles Receives: Drug: Pegylated liposomal doxorubicin; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: At the end of Cycle 3 (each cycle is 21 days)
Secondary outcomes (3)
pCR rate
Pathological complete response rate
Measured: One year after the first intravenous drip
PFS
Progression free survival
Measured: 6 weeks after the first intravenous drip
OS
Overall Survival
Measured: After the first intravenous drip,an average of 3 year through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765228
- Sponsor's protocol ID
- IRB1912212-12
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective One-arm Study of Pegylated Liposomal Doxorubicin Combined With Anlotinib for Neoadjuvant Treatment of Locally Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04765228
- Acronym / sponsor ID
- IRB1912212-12
- Conditions
- Stage III Adult Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Yong ChenUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Feb 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 prospective one-arm study of pegylated liposomal doxorubicin combined with anlotinib for neoadjuvant treatment of locally advanced soft tissue sarcoma.
Detailed description
Tumor angiogenesis is very important in the occurrence and development of soft tissue sarcoma. The current clinical studies of molecularly targeted drugs are focused on the advanced treatment stage of soft tissue sarcoma. Anti-angiogenic drugs are not yet available in the neoadjuvant treatment stage of soft tissue sarcoma. Strong evidence. Therefore, this study aimed to evaluate the safety and effectiveness of pegylated doxorubicin liposomes combined with the anti-angiogenic drug Anlotinib for neoadjuvant treatment of patients with soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated liposomal doxorubicin + Anlotinib | Experimental | Drug: Pegylated liposomal doxorubicin, Drug: AnlotinibPegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2~4 cycles |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with soft tissue sarcoma confirmed by histopathology;
- Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCC staging of soft tissue sarcoma, or tumors that are closely related to important blood vessels and important nerves suggested by imaging data;
- No distant transfer
- According to the preliminary judgment of the research, patients who can improve the effect of surgery by neoadjuvant treatment;
- Male or female, aged ≥14 years old and ≤75 years old;
Key exclusion criteria (11 listed)
- Ewing's sarcoma, embryonic rhabdomyosarcoma, acinar rhabdomyosarcoma
- Pregnant or breastfeeding women, or women who are fertile but have not taken contraceptive measures
- Existing severe acute infection that has not been controlled; or having purulent or chronic infection, and the wound is protracted
- Active hepatitis B or C
- Have a history of other tumors within 5 years before treatment, except for cured cervical carcinoma in situ or skin basal cell carcinoma
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 |
|---|---|---|
| Pegylated liposomal doxorubicinPegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2~4 cycles | Drug | Pegylated liposomal doxorubicin + Anlotinib |
| AnlotinibAnlotinib | Drug | Pegylated liposomal doxorubicin + Anlotinib |
Primary outcome
ORR
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Objective Response Rate
3 secondary outcomes
pCR rate
Time frame: One year after the first intravenous drip
PFS
Time frame: 6 weeks after the first intravenous drip
OS
Time frame: After the first intravenous drip,an average of 3 year through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated liposomal doxorubicin and Anlotinib in people with Stage III Adult Soft Tissue Sarcoma, run by Yong Chen 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 14 inclusion and 11 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 21 Feb 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yong Chen, M.D. (18017317571, chenyong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: At the end of Cycle 3 (each cycle is 21 days)). 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 21 Feb 2021.