Toripalimab Combined With CAV/IE Regimen
ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
Patients voluntarily participated in the study and signed informed consent;
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 least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.
They were 14-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Toripalimab Combined With CAV/IE chemotherapy
- CAV/IE alternate chemotherapy
Treatment groups
134 Participants
are divided into 2 treatment groupsLocations
1Sun Yat-sen University Cancer Center Guangzhou China
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
Source ClinicalTrials.gov