Endostar Combined With Chemotherapy for Stage Ⅳ Soft Tissue Sarcoma

NCT03121833 | Completed Phase 2 DMC

• 1 other identifier: S201601-IIB
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma, Adult, Stage IIB

Keywords

Endostar; Soft Tissue Sarcoma; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 year

Secondary Outcomes (1)

• Disease control rate(DCR）

  2 year

Other Outcomes (3)

• Objective tumor response rate(ORR)

  2 year

• Overall survival(OS)

  3 year

• Adverse Events(AEs)

  2 year

Study Arms (2)

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.

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.

Drug: Placebo; Drug: AIM regimen / GT regimen

Interventions

Endostar DRUG

Recombinant Human Endostatin Injection

Also known as: Recombinant Human Endostatin Injection

Endostar & AIM regimen / GT regimen

Placebo DRUG

500ml 0.9% sodium chloride

Also known as: Placebo(for Endostar)

Placebo & AIM regimen / GT regimen

AIM regimen / GT regimen DRUG

"Pirarubicin (THP) + Ifosfamide (IFO)" / "Docetaxel (TXT) + Gemcitabine (GEM)"

Endostar & AIM regimen / GT regimen; Placebo & AIM regimen / GT regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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;
• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Hospital & Institute

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

endostar protein; Endostatins

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Jilong Yang, M.D., Ph.D.

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)