Glioblastoma
Conditions
Interventions
Trial group:MRG003 combination with temozolomide and radiotherapy for post-resection glioblastoma.
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed glioblastoma meeting the World Health Organization (2021 version) criteria and positive EGFR expression; 2. Undergone surgical resection and based on postoperative MRI, the total resection range is >=95% compared to preoperative MRI (resection for biopsy purposes cannot be enrolled); 3. Age 18–75 years old, no serious heart, lung, liver, kidney and other important organ dysfunction; 4. Estimated survival >=12 weeks; 5. No radiotherapy to the head and neck region prior to enrollment; 6. Laboratory indicators: white blood cell > 3.0×10^9/L, neutrophil > 1.5×10^9/L, platelet count >100×10^9/L, hemoglobin >90g/L; Serum total bilirubin =60mL/min; The upper limit of the normal value of APTT for coagulation parameters was extended by no more than 10 seconds, and the upper limit of normal value of PT was extended by no more than 3 seconds; 7. Subjects and their partners had no family plans from screening to 90 days after the last dose and agreed to use effective contraceptive measures during the trial; 8. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant (confirmed by menstrual blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both for male and female subjects) until at least 3 months after the last trial treatment; 2. Those who have a history of allergy to any component of the drug (MRG003) used in this regimen; 3. Patients with life-threatening cerebral hernia syndrome determined by the investigator, or patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord, or patients with diffuse subependymal disease; 4. Brain MRI showed that the tumor cavity was connected to the ventricle after surgery; 5. History of other malignant tumors within or at the same time with treatment, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid cancer; 6. Has received any of the following treatments: (1) Received PD-1/PD-L1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKIs, and anti-angiogenic drugs within 4 weeks; (2) Received any investigational drug experiment within 4 weeks before the first use of the study drug; (3) Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 7. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA II or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8. Serious infection (CTC AE greater than grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities, etc; 9. Patients with active tuberculosis infection found through medical history or CT examination, or a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection 1 year ago but without formal treatment; 10. Subjects with active hepatitis, HBsAg positive and HBV DNA>=2000IU/ml or 1000 copies/ml, hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method); 11. Known history of psychotropic drug abuse, alcohol abuse and drug abuse; 12. Those who are not suitable for inclusion in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medianprogression-free survival, mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medianoverall survival, mOS;Quality of life; | — |
Countries
China
Contacts
Public ContactZhang Guoyi
The First People's Hospital of Foshan
Outcome results
None listed