Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)

Study Purpose

The goal of this clinical trial is to learn about the induction chemotherapy efficacy in olfactory neuroblastoma. The main question it aims to answer is: wether olfactory neuroblastoma patients with different pathology subtypes apply to different induction chemotherapy schemes. Participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with pathologically confirmed olfactory neuroblastoma; 2. Age ≥ 18 years old; 3. Dulguerov stage T2-T4; 4. Patients who signed the informed consent forms; 5. No distant metastasis.

Exclusion Criteria:

1. Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment; 2. Any situation in which the patient may interfere with the compliance or safety during the study; 3. Severe neurological or mental illness, including dementia and seizures; 4. Uncontrolled active infection; 5. Pregnant or lactating women; 6. Persons without personal freedom and independent capacity for civil conduct; 7. Other situations that are not suitable for joining the group.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06255210
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hongmeng Yu
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hongmeng Yu, Prof.Xicai Sun, MD
Principal Investigator Affiliation	Eye & ENT Hospital, Fudan UniversityEye & ENT Hospital, Fudan University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Olfactory Neuroblastoma

Additional Details

This study included patients with olfactory neuroblastoma who were pathologically diagnosed and met the criteria. According to molecular profiles, two different induction chemotherapy schemes were used to evaluate the tumor remission rate.

Arms & Interventions

Arms

Experimental: Induction chemotherapy in different subtypes of olfactory neuroblastoma

Induction chemotherapy based on pathological molecular subtypes of olfactory neuroblastoma. ① According to the immunohistochemical results of the pathological report, patients with Ki-67 index ≥ 25% were treated with two weeks of gemcitabine+platinum based chemotherapy regimen; ② According to the immunohistochemical results of the pathological report, patients with Ki-67 index <25% were treated with a basic chemotherapy regimen of cyclophosphamide+etoposide+cisplatin (CEP regimen); According to the progression of the patient's disease, the combination of other chemotherapy/small molecule drugs/targeted drugs can be considered;

Interventions

Drug: - Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP)

When the Ki67% index of the tumor is ≥ 25%, patients were treated with the GP regimen for induction chemotherapy; When the Ki67% index of the tumor is < 25%, patients were treated with the CEP regimen for induction chemotherapy.

Contact a Trial Team

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International Sites

Eye & ENT Hospital of Fudan University, Shanghai, Shanghai, China

Status

Recruiting

Address

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai, 200031

Site Contact

Hongmeng Yu, Dr

[email protected]

13501730576

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