Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

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

fractionated radiotherapy (500cGy \*5F, 600cGy\*5F, 350cGy\*10F, according to the tumor volume)

fractionated radiotherapy

cadonilimab

Wei Yu, MD

Qichun Wei, MD/PhD

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

Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard.

The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.

the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment.

Probability of survival for 6 months after treatment

Second Affiliated Hospital, School of Medicine, Zhejiang University

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks

Erbitux®

30-35 fractions of radiotherapy (6-7 weeks)

Fractionated Radiotherapy

Jürgen Debus, Prof. Dr. Dr

This is a national multicenter phase IV study to assess acute radiation dermatitis of combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).

With the aim of optimizing combined treatment strategies in terms of efficacy as well as manageable side effects, the implementation of Cetuximab an EGFR targeting antibody demonstrated successfully a significant increase in survival times, although exhibiting an expected increase in skin toxicities (1,2). This Phase IV trial will explore this prominent side effect, which is due to a synergistic effect of radiodermatitis and acneiform rash, in great detail. In addition, feasibility aspects of the complex treatment schedule in common routine and with patients presenting an increased comorbidity rate compared to the study population studied in the pivotal Phase III trial will be observed.

Further, peripheral blood samples of patients that consent to participate in the molecular monitoring will be collected and their genetic, epigenetic- and transcriptional profiles correlated with clinical outcome parameters. The goal of this translational program is to identify and confirm novel peripheral blood based molecular predictors and surrogates of therapy response. Tissue samples and available medical evidence of patients that consent to participate in the assessment of the HPV status will be collected. The goal of this program is to correlate HPV status with clinical outcome parameters.

In addition, all patients will answer Quality of Life questionnaires including the EORTC QLQ-C30 questionnaire, the Head and Neck cancer specific module (3) and the Dermatology Life Quality Index (DLQI).

This prospective, open, multicenter phase IV study is designed to assess the rate of radiodermatitis in patients with LASCCHN treated with a combination of radiotherapy and the EGFR-targeted monoclonal antibody Cetuximab.

Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE)

Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®

Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab	NCT05737368	Recurrent Gliob...	fractionated ra... cadonilimab	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE)	NCT01553032	Head and Neck C...	Erbitux® Fractionated Ra...	18 Years -	University of Heidelberg Medical Center

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