Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Zhejiang University

Status and phase: Not yet enrolling; Phase 1

Conditions: Recurrent Glioblastoma

Treatments: Drug: cadonilimab; Radiation: fractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05737368

2022-0995

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.

Enrollment: 11 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. . Written and signed informed consent.
2. . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.
3. Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.
4. The maximum diameter of recurrent tumor is less than 6 cm.
5. Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.
6. The interval from the last radiotherapy is more than 6 months.
7. KPS (Karnofsky function status score)>60.

Exclusion criteria

1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
3. Multiple malignant gliomas.
4. Subtentorial glioblastoma or Extracranial metastatic lesions.
5. Active autoimmune diseases.
6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Patients will receive the treatment of fractionated radiotherapy and Cadonilimab

Experimental group

Description:

fractionated radiotherapy (500cGy \*5F, 600cGy\*5F, 350cGy\*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1)

Treatment:

Radiation: fractionated radiotherapy

Drug: cadonilimab