Glioblastoma
Conditions
Interventions
Group A:ACT001 alone
Group B:ACT001 and TMZ combined group
Group C:CCNU or TMZ control
Sponsors
General Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Confirmed by histology and cytology with cerebral patients with glioblastoma (refer to the WHO (2016) of the central nervous system tumor classification, the initial diagnosis is the brain glioblastoma), mo thiazole amine for surgery, radiotherapy and chemotherapy were treated with three kinds of treatments of first recurrent primary GBM patients (according to the pathological test or RANO standard evaluation confirm recurrence); 2. At least one measurable lesion was confirmed according to RANO standard; 3. No previous abnormal bleeding, coagulation function INR = 18 years, regardless of gender; 5. Normal organ function (absolute number of neutrophils [ANC] >= 1.5*10^9/L, lymphocyte >=0.5*10^9/L, platelet >= 75*10^9/L, Hb >=10 g/ dL); Total bilirubin = 60; 9. Female subjects also need to meet the following criteria to be considered for inclusion: a) infertility, defined as: prior hysterectomy or bilateral oophorectomy, or prior bilateral tubal ligation, or menopause (complete menopause >= 1 year). B) be fertile but have a negative serum pregnancy test at the time of screening (within 7 days before the first study drug administration) and agree to use medically approved contraceptive methods (such as IUDs, contraceptives or condoms) before and during the enrolled study until 28 days after the last study drug administration; 10. Sexually active males must agree to use barrier contraception or abstain from sex altogether; 11. Informed consent was signed in person before enrollment study.
Exclusion criteria
Exclusion criteria: 1. Patients who received bevacizumab, iodine in vivo radiation and short cycle radiation therapy within 1 month before enrollment. 2. Patients who received other immunotherapy within 3 months before enrollment, such as DC/CIK/CTL/PD-1/PD-L1, etc. 3. Patients who have received camustine or intracerebral lesion implantation radiotherapy before. 4. Unable to undergo BRAIN MRI examination. 5. Subject has uncontrollable infection (systemic infection within 4 weeks prior to enrollment). 6. HIV (+) or anti HCV (+) or specific antibody (TPHA positive or active hepatitis b (hepatitis b patients also conforms to the selected conditions conforming to the provisions of the following standards: a) the first dosing HBV viral load must II) or stroke (except for luminal infarction). 9. Hypertensive patients with uncontrolled hypertension (systolic blood pressure >= 160 mmHg, diastolic blood pressure >= 100 mmHg). 10. The patient is unable to take oral medication or has gastrointestinal absorption disorders. 11. Presence of uncontrolled seizures and/or high cranial pressure. 12. Uncontrolled spinal cord compression. 13. CT/MRI examination revealed active cerebral hemorrhage. 14. Daily dose (equivalent to) dexamethasone 4 mg or more for three consecutive days or more during the two weeks prior to enrollment. 15. Known to be allergic to ACT001 or similar compounds, or to any component of the ACT001 prescription. 16. Surgery (excluding GBM histopathology) or other anticancer therapy, such as chemotherapy, biotherapy or targeted therapy, immunotherapy or radiation therapy, has been performed within 4 weeks before ACT001 administration. 17. Toxicity due to previous antitumor therapy has not recovered, as defined below: according to CTCAE5.0 evaluation criteria, toxicity has not recovered to < grade 2 (except hair loss, alkaline phosphatase, glutamyl transpeptidase (GGT)). However, in consultation with researchers and sponsors, stable toxicity may be permitted. 18. Other malignancies (excluding adequately treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin and adequately controlled localized basal cell skin cancer) within 5 years prior to enrollment. 19. Women who are pregnant or breastfeeding. 20. Other reasons for not being suitable for this study were determined by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-Year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Disease control rate;The incidence and frequency of adverse events;Vital signs, etc;Laboratory examination;ECG; | — |
Countries
China
Contacts
Public ContactXuejun Yang
General Hospital of Tianjin Medical University
Outcome results
None listed