Clinical trial · Interventional
Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme
NCT05589961CI-TRIAL-00061616unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the safety of an innovative integrated treatment regimen for recurrent glioblastoma , including patients with recurrent glioblastoma multiforme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TMZ | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- integrated treatment regimen(TRPP)
- interventionNames
- Drug: TMZ
Primary outcomes (1)
- measure
- To Evaluate the Safety of the Integrated Treatment Regimen for Glioblastoma Multiforme
- timeFrame
- From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 21 days)
- description
- Evaluating the possible adverse reactions recorded are analyzed, mainly including the number, incidence and severity of radiochemotherapy-related adverse reactions and immune-related adverse reactions (irAE) from the beginning of treatment to the progression of disease. Include: 1. Systemic reaction: such as dizziness, fatigue, bone or muscle pain, etc.; 2. drug allergic reaction; 3. Cytopenia caused by myelosuppression may lead to severe infection, bleeding, anemia, etc.; 4. Gastrointestinal symptoms such as loss of appetite, nausea, vomiting, abdominal pain, diarrhea, constipation, fecal occult blood, gastrointestinal bleeding, etc.; 5. Immune-related adverse reactions (irAE) : Pneumonia, including immune correlation immunity correlation colitis, correlation immune correlation hepatitis, nephritis, immune related endocrine diseases, immune correlation skin reactions and other immune system Related adverse reactions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The pathological result of glioblastoma WHO grade 4; * Received standard TMZ chemotherapy and radiotherapy; * It is not suitable to undergo surgical resection of the lesion again or other drug treatment, or the patient refuses other treatment; * Men and women aged 18-75; * Disease progression was confirmed by CT or MRI examination within 4 weeks before enrollment; * KPS score ≥70; * Expected survival time ≥ 3 months, and can meet the follow-up requirements; * Within 7 days before the start of treatment, the results of routine blood tests, liver and renal function tests, and hemagglutination laboratory tests meet the following criteria: Leukocyte (WBC) ≥ 3.0×109/L Platelets (PLT) ≥ 100×109/L Neutrophil (ANC) ≥ 1.5×109/L Hemoglobin (HGB) ≥ 90g/L Serum albumin ≥2.8g/dL Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN) (\< 5×ULN for liver metastases) Alanine aminotransferase (ALT) ≤2.5×ULN (≤5×ULN for liver metastases) Total bilirubin (TIBC) ≤1.5×ULN, patients with liver cancer or liver metastases should ≤2×ULN Serum creatinine (CR)≤1.5×ULN or creatinine clearance ≥50ml/min AST and ALT levels ≤ 2.5×ULN, and patients with liver metastases or liver cancer should ≤ 5×ULN International Normalized ratio (INR) ≤ 1.5 Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN * Pregnancy should be ruled out for fertile women, and HCG tests for early pregnancy must be negative; Both male and female participants should ensure that they use contraception during the study and continue to use contraception until the end of the follow-up period; * Volunteer to participate in the clinical study, cooperate with the doctor to carry out the study, and sign the informed consent form. Exclusion Criteria: * Participating in another clinical trial; * Recurrence within 4 weeks after surgery; * Recurrence within 4 weeks after chemotherapy; * Recurrence within 4 weeks after radiotherapy; * Increased intracranial pressure: midline shift ≥5mm, clinically significant visual edema, vomiting and nausea, or poor level of consciousness; * Have active infection that is not controlled with appropriate anti-infective therapy; * Patients with mental illness or other conditions, such as uncontrollable heart disease or lung disease, diabetes, etc., cannot comply with the requirements of research treatment and monitoring; * Organ transplants; * Pregnant or lactating women; Persons with disabilities (blind, deaf, dumb, mentally disabled, physically disabled) or suffering from mental diseases as prescribed by law; Drug users or patients with a history of adverse drug abuse and alcohol dependence within 5 years; * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as a positive hepatitis B surface antigen \[HBsAg\] test, HBV-DNA ≥ 500 IU/ml and abnormal liver function; Hepatitis C, defined as hepatitis C antibody \[HCV-AB\] positive, HCV-RNA above the detection limit of the assay, and abnormal liver function) or co-infection with hepatitis B and C; * Any other factors that the investigator deems inappropriate for the subject to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.