Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

NCT ID: NCT05589961

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-07-31

Brief Summary

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.

Detailed Description

This study is a single-center, prospective, open-label, single-arm clinical study of an innovative integrated treatment regimen for recurrent glioblastoma multiforme.

The main outcome measurement of the study is to evaluate the safety of the integrated treatment regimen for glioblastoma multiforme. Secondary outcome measurement are OS, PFS, ORR, and quality of life. Safety is evaluated by monitoring adverse events, physical examination results, vital signs, ECG, hematology, and clinical biochemistry. Imaging was performed at the end of every 3 sessions to assess treatment outcome and disease progression. The whole treatment and efficacy will be observed for two years.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

integrated treatment regimen(TRPP)

Group Type: EXPERIMENTAL

TMZ

Intervention Type: DRUG

After enrollment, temozolomide 50mg/m2 was given orally for QD until progression, and radiotherapy and PF 0.2g/ time for TID were started one week later until progression. Pembrolizumab 200mg once every 3 weeks until progression; The radiotherapy regimen depends on the patient's recurrence and initial treatment.

Interventions

TMZ

After enrollment, temozolomide 50mg/m2 was given orally for QD until progression, and radiotherapy and PF 0.2g/ time for TID were started one week later until progression. Pembrolizumab 200mg once every 3 weeks until progression; The radiotherapy regimen depends on the patient's recurrence and initial treatment.

Intervention Type: DRUG

Other Intervention Names

PD-1; RF

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunyan Li, Academician

Role: STUDY_CHAIR

The Second Hospital of Hebei Medical University

Locations

the Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunyan Li, Academician

Role: CONTACT

hebeichunyanli@aliyun.com

0311-87064024

Other Identifiers

HebeiSH_GBM_V1.0

Identifier Type: -

Identifier Source: org_study_id