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New treatment option for Soft Tissue Sarcoma
Official title Toripalimab Combined With CAV/IE Regimen
ClinicalTrials.gov ID: NCT04589741
What this study is testing
What is Toripalimab Combined With CAV/IE chemotherapy?
Toripalimab Combined With CAV/IE chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for soft tissue sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study was to investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 70
You may be able to join if
- Patients voluntarily participated in the study and signed informed consent; For all advanced or non resectable bone and soft tissue sarcomas...
- Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;
- In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured...
- They were 14-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;
- Within 7 days before treatment, the main organ functions met the following criteria: (1) Blood routine examination standard (without blood...
You likely can't join if
- 1) Patients who had previously received anti-PD-1 / PD-L1 antibody therapy. 2) Other malignancies occurred or were present within 5 years, except for...
- Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);
- Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure...
- Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);
- Chronic liver disease, decompensated liver disease or decompensated hepatitis;
- Renal failure needs hemodialysis or peritoneal dialysis;
See the full eligibility criteria
- Patients voluntarily participated in the study and signed informed consent; For all advanced or non resectable bone and soft tissue sarcomas confirmed by pathology, the standard treatment failed or there was no standard...
- Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;
- In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at...
- They were 14-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;
- Within 7 days before treatment, the main organ functions met the following criteria: (1) Blood routine examination standard (without blood transfusion within 14 days) ① Hemoglobin (HB) ≥ 90g / L; ② The absolute value of...
- Platelet (PLT) ≥ 80 × 109 / L. (2) Biochemical examination should meet the following standards:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln; ALT and AST ≤ 5uln with liver metastasis
- Serum creatinine (CR) ≤ 1.5uln or creatinine clearance rate (CCR) ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%). 6)Women of...
- 1) Patients who had previously received anti-PD-1 / PD-L1 antibody therapy. 2) Other malignancies occurred or were present within 5 years, except for cervical carcinoma in situ, non melanoma skin cancer and superficial...
- Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);
- Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2;
- Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);
- Chronic liver disease, decompensated liver disease or decompensated hepatitis;
- Renal failure needs hemodialysis or peritoneal dialysis;
- Poor control of diabetes mellitus (FBG \> 10mmol / L);
- Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;
- Patients with epilepsy and need treatment; 7) Major surgical treatment, open biopsy or obvious traumatic injury were performed within 28 days before admission; 8) Patients with any physical signs or history of bleeding...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.