Advanced soft tissue sarcoma
Conditions
Interventions
1:Fluzoparib combined with temozolomide
Sponsors
Department of Orthopaedic Oncology, First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced soft-tissue sarcoma who have previously received at least one-line chemotherapy failure, and advanced soft-tissue sarcoma diagnosed by pathology have at least one measurable lesion; 2. Aged 18-70 years; 3. ECOG PS score: 0-2; 4. Expected survival of more than 3 months; 5. The patient received the last treatment (at least 4 weeks after chemotherapy, radiotherapy, biological therapy or other research drugs or an elutation period of more than 5 half-lives); toxicity from previous antineoplastic therapy has reverted to <= 1 (NCI-CTCAE 5.0), except for hair loss, etc.; 6. Previously used targeted drugs with different mechanisms of action from fluzopali, such as apatinib, mTOR inhibitors, Iressa/Trokai/Kemena, etc., and stopped for more than 4 weeks.
Exclusion criteria
Exclusion criteria: Patients with any of the following items will not be enrolled in this study; 1. Previous (within 5 years) or at the same time with other malignant tumors, except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ; 2. Subjects have previously used PARP inhibitors and/or have previously used temozolomide; 3. Those who have hypertension and cannot be well controlled by antihypertensive drugs; 4. Those who have participated in clinical trials of other drugs within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;ORR, Objective Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, Progression-Free Survival;OS, Overall Survival;DCR, Disease Control Rate;safety; | — |
Countries
China
Contacts
Public ContactJingnan Shen
The First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed