Other Disorders of Soft TissuesPhase 2NCT04699214
Endostar Combined With AI Regimen Compared With AI in Adjuvant Treatment
A Phase 2 study testing Endostar (recombinant human endostatin injection) and Chemotherapy AI in people with Other Disorders of Soft Tissues, run by Yong Chen at 1 site in China.
Trial summary
To evaluate the effectiveness, safety and tolerability of Endostar (recombinant human endostatin) combined with AI chemotherapy in adjuvant treatment after radical resection of recurrent soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Other Disorders of Soft Tissues
- What is being tested?
- Endostar (recombinant human endostatin injection) and Chemotherapy AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Aug 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with soft tissue sarcoma confirmed by histopathology and cytology;
- Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCC staging of soft tissue sarcoma;
- Patients who have previously undergone surgery can be included in the group, but according to the researcher's evaluation, they must have recovered and the operation completion time is at least 4 weeks from the study entry;
- Local radiotherapy can be received during chemotherapy;
- Have received anti-tumor drug treatment in the past, including adjuvant or neoadjuvant chemotherapy, but it has been over 6 months before the start of the study treatment;
- R0 resection after local recurrence, non-chemotherapeutic resistant soft tissue sarcoma, including synovial sarcoma, pleomorphic liposarcoma, myxoid/round cell liposarcoma, pleomorphic undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, Angiosarcoma, malignant peripheral nerve sheath tumor, epithelioid sarcoma, etc., except Ewing's sarcoma, embryonic/acinoid rhabdomyosarcoma and other sarcomas that do not use AI regimen as the first-line chemotherapy regimen, and some chemotherapy-insensitive sarcomas: highly differentiated/removed Differentiated liposarcoma, clear cell sarcoma, alveolar soft tissue sarcoma, extraosseous mucinous chondrosarcoma, etc.;
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- No gender limit, ≥18 years old;
- ECOG score ≤ 2;
- The expected survival period is ≥3 months;
- Sufficient blood 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 upper limit of normal (ULN); alkaline phosphatase ≤ 5 times upper limit of normal (ULN);
- Sufficient renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min;
- The electrocardiogram is basically normal, and there is no unhealed wound on the body;
- Those who have not had a severe allergic reaction to biological agents, especially E. coli genetic engineering products;
- Women of childbearing age must 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 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
- Pregnant or lactating women, or female patients who are fertile but have not taken contraceptive measures;
- There are severe acute infections that have not been controlled; or there are purulent and chronic infections, and the wounds do not heal;
- There is a second primary tumor (except skin basal cell carcinoma);
- Those who have participated in other drug clinical trials within 4 weeks.
- Pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
- People with uncontrollable neurological or mental illnesses or mental disorders, poor compliance, and 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;
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- Those with bleeding tendency;
- Evidence of hereditary hemorrhagic constitution or coagulopathy;
- 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 Yong, Doctor, 13917530417, chenyong@fudan.edu.cn
Dong Yan, master, 15259205312, dongyan20202020@126.com
About this study
Official title: A Prospective, Randomized Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Endostar Combined With AI Regimen Compared With AI Regimen in Adjuvant Treatment After Radical Resection of Recurrent Soft Tissue Sarcoma
To evaluate the effectiveness, safety and tolerability of Endostar (recombinant human endostatin) combined with AI chemotherapy in adjuvant treatment after radical resection of recurrent soft tissue sarcoma.
Read the detailed description
Eligible patients with stage IIB/III soft tissue sarcoma after surgical treatment for local recurrence were randomly divided into three groups:
Group A: Endostar combined chemotherapy AI Endostar: Endostar 45mg/d, D1-5 iv, Q3W, that is, continuous intravenous pump injection for 120 hours for 5 consecutive days, one cycle. Endostar takes 15 medicines per cycle, and a Baxter pump per single cycle. Subjects buy and use them at their own expense every two cycles.
AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W.
Group B:Chemotherapy AI AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W.
Group C: Observation group Best supportive treatment, observation and follow-up. The dose of Endostar is not adjusted, and the specific adjustment plan of the chemotherapy regimen is adjusted according to the clinical experience of the investigator.
Patients with no disease progression (local tumor recurrence, distant metastasis, or the appearance of new lesions of the same tumor subtype) and the adverse reactions can be tolerated, continue to use the drug for 6 cycles, and cannot receive other anti-tumor treatments. During the medication, if the disease progresses or the researcher believes that the patient is not suitable for continuing medication, the medication will end.
- Conditions
- Other Disorders of Soft Tissues
- Being tested
- Endostar (recombinant human endostatin injection), Chemotherapy AI
- Keywords
- OS（Overall Survival）, EFS（Event-Free Survival Rate）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostar (recombinant human endostatin injection)Drug
The experimental group is Endostar combined with AI
Chemotherapy AIDrug
AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Endostar combined with chemotherapy AI | Experimental | Endostar: Endostar 45mg/d, D1-5 iv, Q3W, that is, continuous intravenous pump injection for 120 hours for 5 consecutive days, one cycle. Endostar uses 15 medicines per cycle, 15 Endostar medicines and a Baxter pump per single cycle. Subjects buy and use them at their own expense every two cycles.
AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W. Receives: Drug: Endostar (recombinant human endostatin injection) |
| Chemotherapy AI | Active comparator | AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W. Receives: Drug: Chemotherapy AI |
| Observation group | Placebo comparator | The dose of Endostar is not adjusted, and the specific adjustment plan of the chemotherapy regimen is adjusted according to the clinical experience of the investigator.
Patients with no disease progression (local tumor recurrence, distant metastasis, or the appearance of new lesions of the same tumor subtype) and the adverse reactions can be tolerated, continue to use the drug for 6 cycles, and cannot receive other anti-tumor treatments. In the course of medication, if the disease progresses or the researcher believes that the patient is not suitable for continuing medication, the medication will end. Receives: Drug: Endostar (recombinant human endostatin injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS （Event-Free Survival Rate）
Prospective observation of the 2-year event-free survival rate EFS (Event-Free Survival Rate) of recombinant human endostatin injection (Endostar, trade name: Endostar) combined with adjuvant chemotherapy for local recurrence of soft tissue sarcoma, ie no progress , No disease-related deaths, no time for new lesions.
Measured: 2 year
Secondary outcomes (1)
OS（Overall Survival）
To evaluate the OS (Overall Survival)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Sep 2020
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Disorders of Soft TissuesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled, open phase II clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 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
- NCT04699214
- Sponsor's protocol ID
- 1906203-3
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be announced after the clinical trial is over.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Endostar Combined With AI Regimen Compared With AI Regimen in Adjuvant Treatment After Radical Resection of Recurrent Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04699214
- Acronym / sponsor ID
- 1906203-3
- Conditions
- Other Disorders of Soft Tissues
- Keywords
- OS（Overall Survival）, EFS（Event-Free Survival Rate）
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Yong ChenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 7 Jan 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.
To evaluate the effectiveness, safety and tolerability of Endostar (recombinant human endostatin) combined with AI chemotherapy in adjuvant treatment after radical resection of recurrent soft tissue sarcoma.
Detailed description
Eligible patients with stage IIB/III soft tissue sarcoma after surgical treatment for local recurrence were randomly divided into three groups:
Group A: Endostar combined chemotherapy AI Endostar: Endostar 45mg/d, D1-5 iv, Q3W, that is, continuous intravenous pump injection for 120 hours for 5 consecutive days, one cycle. Endostar takes 15 medicines per cycle, and a Baxter pump per single cycle. Subjects buy and use them at their own expense every two cycles.
AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W.
Group B:Chemotherapy AI AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W.
Group C: Observation group Best supportive treatment, observation and follow-up. The dose of Endostar is not adjusted, and the specific adjustment plan of the chemotherapy regimen is adjusted according to the clinical experience of the investigator.
Patients with no disease progression (local tumor recurrence, distant metastasis, or the appearance of new lesions of the same tumor subtype) and the adverse reactions can be tolerated, continue to use the drug for 6 cycles, and cannot receive other anti-tumor treatments. During the medication, if the disease progresses or the researcher believes that the patient is not suitable for continuing medication, the medication will end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective, randomized controlled, open phase II clinical study
| Arm | Type | Receives |
|---|---|---|
| Endostar combined with chemotherapy AI | Experimental | Drug: Endostar (recombinant human endostatin injection)Endostar: Endostar 45mg/d, D1-5 iv, Q3W, that is, continuous intravenous pump injection for 120 hours for 5 consecutive days, one cycle. Endostar uses 15 medicines per cycle, 15 Endostar medicines and a Baxter pump per single cycle. Subjects buy and use them at their own expense every two cycles. AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W. |
| Chemotherapy AI | Active comparator | Drug: Chemotherapy AIAI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W. |
| Observation group | Placebo comparator | Drug: Endostar (recombinant human endostatin injection)The dose of Endostar is not adjusted, and the specific adjustment plan of the chemotherapy regimen is adjusted according to the clinical experience of the investigator. Patients with no disease progression (local tumor recurrence, distant metastasis, or the appearance of new lesions of the same tumor subtype) and the adverse reactions can be tolerated, continue to use the drug for 6 cycles, and cannot receive other anti-tumor treatments. In the course of medication, if the disease progresses or the researcher believes that the patient is not suitable for continuing medication, the medication will end. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with soft tissue sarcoma confirmed by histopathology and cytology;
- Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCC staging of soft tissue sarcoma;
- Patients who have previously undergone surgery can be included in the group, but according to the researcher's evaluation, they must have recovered and the operation completion time is at least 4 weeks from the study entry;
- Local radiotherapy can be received during chemotherapy;
- Have received anti-tumor drug treatment in the past, including adjuvant or neoadjuvant chemotherapy, but it has been over 6 months before the start of the study treatment;
Key exclusion criteria (9 listed)
- Pregnant or lactating women, or female patients who are fertile but have not taken contraceptive measures;
- There are severe acute infections that have not been controlled; or there are purulent and chronic infections, and the wounds do not heal;
- There is a second primary tumor (except skin basal cell carcinoma);
- Those who have participated in other drug clinical trials within 4 weeks.
- Pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
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 |
|---|---|---|
| Endostar (recombinant human endostatin injection)The experimental group is Endostar combined with AI | Drug | Endostar combined with chemotherapy AI, Observation group |
| Chemotherapy AIAI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W | Drug | Chemotherapy AI |
Primary outcome
EFS （Event-Free Survival Rate）
Time frame: 2 year
Prospective observation of the 2-year event-free survival rate EFS (Event-Free Survival Rate) of recombinant human endostatin injection (Endostar, trade name: Endostar) combined with adjuvant chemotherapy for local recurrence of soft tissue sarcoma, ie no progress , No disease-related deaths, no time for new lesions.
1 secondary outcome
OS（Overall Survival）
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: Undecided. IPD will be announced after the clinical trial is over.
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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 Endostar (recombinant human endostatin injection) and Chemotherapy AI in people with Other Disorders of Soft Tissues, 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 16 inclusion and 9 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 7 Jan 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS （Event-Free Survival Rate） (time frame: 2 year). 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 7 Jan 2021.