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

Hongmeng Yu

Status and phase: Enrolling; Phase 2

Conditions: Olfactory Neuroblastoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06255210

ONB-NACT-V1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Induction chemotherapy in different subtypes of olfactory neuroblastoma

Experimental group

Description:

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;

Treatment:

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