Soft Tissue Sarcoma, Adult, Stage IIBPhase 2NCT03121833
Endostar Combined With Chemotherapy for Stage Ⅳ Soft Tissue Sarcoma
A Phase 2 study testing Endostar and AIM regimen / GT regimen in people with Soft Tissue Sarcoma, Adult, Stage IIB, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for stage IV 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, Adult, Stage IIB
- What is being tested?
- Endostar and AIM regimen / GT regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 20 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients volunteered to participate in this study, signed informed consent;
- Pathological diagnosis of stage Ⅳ of soft tissue sarcoma patients, clinical staging using the American Cancer Research Joint Commission (AJCC) TNM staging criteria. There is at least one extracranial measurable lesion based on CT or MRI.
- 18 to 75 years old; the patient's physical condition Karnofsky score ≧ 60 points; ECG, blood, liver and kidney function were no abnormalities; expected survival ≧ 6 months.
- Major organ function within 7 days prior to treatment, meeting the following criteria:
- Blood routine examination criteria (14 days without blood transfusion):
- ①hemoglobin (HB) ≥ 90g / L;② neutrophil absolute value (ANC) ≥ 1.5 × 109 / L;③ platelet (PLT) ≥ 80 × 109 / L.
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- Biochemical tests to meet the following criteria:
- ①Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN, such as liver metastasis, the ALT and AST ≤ 5×ULN;③ Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60ml / min;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low (50%).
- Women of childbearing age should agree that contraceptive measures (such as intrauterine devices, birth control pills or condoms) must be used within the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to the study For non-lactating patients; men should agree to patients who have contraindications during the study period and within 6 months after the end of the study period.
Who cannot join
- Patients who had previously used Endostar injections;
- Patients who have received antiangiogenic therapy or other targeted treatment for no more than 3 months, such as Endostar, Erlotinib, Sunitinib, Sorafenib, Avastin, Imatinib, Famitinib, Pazopanib and other drugs.
- 5 years or present at the same time suffering from other malignant tumors. Cured cervix in situ cancer, non-melanoma skin cancer and superficial bladder tumors except. [Ta (non-invasive tumor), Tis (orthotopic carcinoma) and T1 (tumor infiltrating basement membrane)];
- During the first 4 weeks of the group or during the study period, systemic anti-tumor therapy was planned, including cytotoxic therapy and immunotherapy. Intravenous radiotherapy (EF-RT) was performed 4 weeks prior to grouping or restricted radiotherapy was performed within 2 weeks prior to grouping to assess tumor lesions;
- Due to any previous treatment caused by the CTC AE (4.0) level 1 or more of the mitigated toxicity, excluding hair loss;
- Patients with symptoms or symptoms of control less than 2 months of brain metastases;
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- Any patient with severe and / or uncontrolled disease, including:
- Patients with poor blood pressure control. (Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg);
- Myocardial ischemia or myocardial infarction, arrhythmia (including QTC ≥480 ms) and ≥ 2 levels of congestive heart failure (NYHA classification)
- Active or uncontrollable serious infections (≥CTC AE Level 2 infection);
- Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis to be treated with antiretroviral therapy;
- Renal failure requires hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positive or other acquired, congenital immune deficiency disease, or a history of organ transplantation;
- Poor control of diabetes (fasting blood glucose (FBG)> 10mmol / L);
- Urine Urine Urine protein ≥ ++, and confirmed 24 hours urine protein> 1.0 g;
- Patients with a seizure and need treatment.
- Significant surgical treatment, biopsy or traumatic injury was received within 28 days prior to the grouping;
- Regardless of the severity of the presence of any signs of bleeding or medical history of patients; in the first 4 weeks before the group, any bleeding or bleeding events ≥ CTCAE3 patients, there is no healing wounds, ulcers or fractures;
- Subluxation / venous thrombosis events occurred within 6 months before the group, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- Have a history of psychiatric abuse and can not quit or have mental disorders;
- Four weeks before the group participated in other clinical trials of anti-tumor drugs;
- According to the researcher's judgment, there are other comorbidities that seriously endanger the safety of the patient or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Hospital & Institute
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Randomized, Double-blind, Placebo-controlled (2: 1), Multicenter Clinical Study (IIB) for the Treatment of Stage Ⅳ Soft Tissue Sarcoma With Recombinant Human Endostatin(Endostar) Combined With Chemotherapy
This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for stage IV soft tissue sarcoma.
Read the detailed description
The prognosis of sarcoma patients in stage IV is poor. For STS, the response rate of chemotherapy is only 20-35% and the median survival time is about 12 months. The 5 year survival rate is lower than 10% reported in several large-scale studies. Although chemotherapy plays a major role in the treatment of advanced STS, the classic chemotherapy agents are not curative. Combination chemotherapy or dose-dense regimens have largely failed to improve the response rates. Long-term using of cytotoxic drugs increased the risk of toxicity in patients. Endostatin is the strongest endogenous angiogenesis inhibitor, which inhibits vascular endothelial growth factor (VEGF) expression and then inhibits tumor angiogenesis . Endostar, is a novel recombinant human endostatin, with advantages of long half-life, stable and low cost. Recently, a study of Endostar combined with chemotherapy in the treatment of advanced soft tissue sarcoma indicated resulted in a higher clinical benefit response (CBR) and longer progression-free survival (PFS), with tolerable side effects. However this study included the patients with stage IIB-IV soft tissue sarcomas and did not include specific pathologic information. Thus this clinical trial is designed to compare the efficacy and safety of endostar combined with chemotherapy versus chemotherapy alone in stage IV patients with soft tissue sarcomas.
- Conditions
- Soft Tissue Sarcoma, Adult, Stage IIB
- Being tested
- Endostar, Placebo, AIM regimen / GT regimen
- Keywords
- Endostar, Soft Tissue Sarcoma, Chemotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
Also called Recombinant Human Endostatin Injection
Recombinant Human Endostatin Injection
PlaceboDrug
Also called Placebo(for Endostar)
500ml 0.9% sodium chloride
AIM regimen / GT regimenDrug
"Pirarubicin (THP) + Ifosfamide (IFO)" / "Docetaxel (TXT) + Gemcitabine (GEM)"
| Study group | Role | What they receive |
|---|---|---|
| Endostar & AIM regimen / GT regimen | Experimental | Endostar \& AIM regimen / GT regimen; Endostar 15mg, into 500ml 0.9% sodium chloride intravenous infusion of 3 ~ 4h, d1 ~ d14, 21-28 days for a cycle; AIM regimen is Pirarubicin (THP) + Ifosfamide (IFO), the specific dose is IFO 8-12g / m2, given 4-5 days; THP 75mg / m2, given 1-2 days; 21-28 days for a cycle; GT regimen is Docetaxel (TXT) + Gemcitabine (GEM), specific dose of Gemcitabine 1000mg / m2 (D1, D8) and Docetaxel 75mg / m2 (D8); 21-28 days for a cycle; Preferred AIM regimen, AIM regimen chemotherapy failure or can not tolerate anthracycline chemotherapy in patients with GT regimen. Receives: Drug: Endostar; Drug: AIM regimen / GT regimen |
| Placebo & AIM regimen / GT regimen | Placebo comparator | Placebo + AIM regimen / GT regimen; Placebo is 500ml 0.9% sodium chloride, Intravenous 3 ~ 4h, d1 ~ d14, 21-28 days for a cycle; The chemotherapy regimen is the same as the experimental group. Receives: Drug: Placebo; Drug: AIM regimen / GT regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Measured: 2 year
Secondary outcomes (1)
Disease control rate(DCR）
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）
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 posted20 Apr 2017
- Study start1 May 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma, Adult, Stage IIBStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of 150 cases, according to 2: 1 random into the group. Among them, 100 cases of Endostar combined chemotherapy group, 50 cases of placebo + chemotherapy group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jilong Yang, M.D., Ph.D., Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121833
- Sponsor's protocol ID
- S201601-IIB
- Status last verified
- Dec 2019
- First submitted
- 17 Apr 2017
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled (2: 1), Multicenter Clinical Study (IIB) for the Treatment of Stage Ⅳ Soft Tissue Sarcoma With Recombinant Human Endostatin(Endostar) Combined With Chemotherapy
- ClinicalTrials.gov ID
- NCT03121833
- Acronym / sponsor ID
- S201601-IIB
- Conditions
- Soft Tissue Sarcoma, Adult, Stage IIB
- Keywords
- Endostar, Soft Tissue Sarcoma, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 20 Apr 2017 (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.
This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for stage IV soft tissue sarcoma.
Detailed description
The prognosis of sarcoma patients in stage IV is poor. For STS, the response rate of chemotherapy is only 20-35% and the median survival time is about 12 months. The 5 year survival rate is lower than 10% reported in several large-scale studies. Although chemotherapy plays a major role in the treatment of advanced STS, the classic chemotherapy agents are not curative. Combination chemotherapy or dose-dense regimens have largely failed to improve the response rates. Long-term using of cytotoxic drugs increased the risk of toxicity in patients. Endostatin is the strongest endogenous angiogenesis inhibitor, which inhibits vascular endothelial growth factor (VEGF) expression and then inhibits tumor angiogenesis . Endostar, is a novel recombinant human endostatin, with advantages of long half-life, stable and low cost. Recently, a study of Endostar combined with chemotherapy in the treatment of advanced soft tissue sarcoma indicated resulted in a higher clinical benefit response (CBR) and longer progression-free survival (PFS), with tolerable side effects. However this study included the patients with stage IIB-IV soft tissue sarcomas and did not include specific pathologic information. Thus this clinical trial is designed to compare the efficacy and safety of endostar combined with chemotherapy versus chemotherapy alone in stage IV patients with soft tissue sarcomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 150 cases, according to 2: 1 random into the group. Among them, 100 cases of Endostar combined chemotherapy group, 50 cases of placebo + chemotherapy group.
| Arm | Type | Receives |
|---|---|---|
| Endostar & AIM regimen / GT regimen | Experimental | Drug: Endostar, Drug: AIM regimen / GT regimenEndostar \& AIM regimen / GT regimen; Endostar 15mg, into 500ml 0.9% sodium chloride intravenous infusion of 3 ~ 4h, d1 ~ d14, 21-28 days for a cycle; AIM regimen is Pirarubicin (THP) + Ifosfamide (IFO), the specific dose is IFO 8-12g / m2, given 4-5 days; THP 75mg / m2, given 1-2 days; 21-28 days for a cycle; GT regimen is Docetaxel (TXT) + Gemcitabine (GEM), specific dose of Gemcitabine 1000mg / m2 (D1, D8) and Docetaxel 75mg / m2 (D8); 21-28 days for a cycle; Preferred AIM regimen, AIM regimen chemotherapy failure or can not tolerate anthracycline chemotherapy in patients with GT regimen. |
| Placebo & AIM regimen / GT regimen | Placebo comparator | Drug: Placebo, Drug: AIM regimen / GT regimenPlacebo + AIM regimen / GT regimen; Placebo is 500ml 0.9% sodium chloride, Intravenous 3 ~ 4h, d1 ~ d14, 21-28 days for a cycle; The chemotherapy regimen is the same as the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients volunteered to participate in this study, signed informed consent;
- Pathological diagnosis of stage Ⅳ of soft tissue sarcoma patients, clinical staging using the American Cancer Research Joint Commission (AJCC) TNM staging criteria. There is at least one extracranial measurable lesion based on CT or MRI.
- 18 to 75 years old; the patient's physical condition Karnofsky score ≧ 60 points; ECG, blood, liver and kidney function were no abnormalities; expected survival ≧ 6 months.
- Major organ function within 7 days prior to treatment, meeting the following criteria:
- Women of childbearing age should agree that contraceptive measures (such as intrauterine devices, birth control pills or condoms) must be used within the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to the study For non-lactating patients; men should agree to patients who have contraindications during the study period and within 6 months after the end of the study period.
Key exclusion criteria (22 listed)
- Patients who had previously used Endostar injections;
- Patients who have received antiangiogenic therapy or other targeted treatment for no more than 3 months, such as Endostar, Erlotinib, Sunitinib, Sorafenib, Avastin, Imatinib, Famitinib, Pazopanib and other drugs.
- 5 years or present at the same time suffering from other malignant tumors. Cured cervix in situ cancer, non-melanoma skin cancer and superficial bladder tumors except. [Ta (non-invasive tumor), Tis (orthotopic carcinoma) and T1 (tumor infiltrating basement membrane)];
- During the first 4 weeks of the group or during the study period, systemic anti-tumor therapy was planned, including cytotoxic therapy and immunotherapy. Intravenous radiotherapy (EF-RT) was performed 4 weeks prior to grouping or restricted radiotherapy was performed within 2 weeks prior to grouping to assess tumor lesions;
- Due to any previous treatment caused by the CTC AE (4.0) level 1 or more of the mitigated toxicity, 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 |
|---|---|---|
| EndostarAlso: Recombinant Human Endostatin InjectionRecombinant Human Endostatin Injection | Drug | Endostar & AIM regimen / GT regimen |
| PlaceboAlso: Placebo(for Endostar)500ml 0.9% sodium chloride | Drug | Placebo & AIM regimen / GT regimen |
| AIM regimen / GT regimen"Pirarubicin (THP) + Ifosfamide (IFO)" / "Docetaxel (TXT) + Gemcitabine (GEM)" | Drug | Endostar & AIM regimen / GT regimen, Placebo & AIM regimen / GT regimen |
Primary outcome
Progression-free survival (PFS)
Time frame: 2 year
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
1 secondary outcome
Disease control rate(DCR）
Time frame: 2 year
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 26 Dec 2019.
- Individual participant dataSharing planned: No
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.
Jilong Yang, M.D., Ph.D. study chair
Tianjin Medical University Cancer Institute and Hospital
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 and AIM regimen / GT regimen in people with Soft Tissue Sarcoma, Adult, Stage IIB, run by Tianjin Medical University Cancer Institute and 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 10 inclusion and 22 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 26 Dec 2019. 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?
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?
Progression-free survival (PFS) (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 26 Dec 2019; AzTrials last refreshed its copy on 3 Nov 2026.