Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients

NCT06389201 | Recruiting DMC

• 1 other identifier: 2024HCQ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn the investigators' attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, the investigators report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer. Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma

Keywords

autophagy; tumor dormancy; nasopharyngeal carcinoma; recurrence; metastasis

Outcome Measures

Primary Outcomes (1)

• Recurrence and metastasis

  After the patients are diagnosed and treated, CT scans is used semi-annually to determine the progression, recurrence and metastasis of tumor.

  Five to Ten years.

Study Arms (2)

Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy

EXPERIMENTAL

Hydroxychloroquine (HCQ), is used one day before chemotherapy and radiotherapy, 400-600mg, oral tablet, once. During chemotherapy and radiotherapy, HCQ maintenance dose is 200-400mg daily.

Drug: HCQ

Receive placebo before and during chemotherapy and radiotherapy

PLACEBO COMPARATOR

Placebos are used one day before chemotherapy and radiotherapy, and during the therapy.

Other: Placebo

Interventions

HCQ DRUG

HCQ, 400-600mg, oral tablet, once, one day before chemotherapy and radiotherapy. During therapy, HCQ maintenance dose is 200-400mg daily.

Also known as: Hydroxychloroquine

Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy

Placebo OTHER

Placebo, oral tablet, once, one day before chemotherapy and radiotherapy. During therapy, placebo maintenance oral tablet once daily.

Receive placebo before and during chemotherapy and radiotherapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of NPC.
• Have not received any cancer therapies
• Must provide informed consent

You may not qualify if:

• With metastasis before the first treatment.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Bo You

Nantong, Jiangsu, 226000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Recurrence; Neoplasm Metastasis

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bo You, Doctor

  Department of Otorhinolaryngology-Head and Neck Surgery, Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo You, Doctor

CONTACT

+8615851358688; youbo19891014@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2034
• Last Updated: February 18, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Two years after this clinical trial finished.
• Access Criteria: Researchers must clearly state the purpose of their study and ensure it aligns with the scientific objectives of the data sharing initiative. A detailed research plan, including research design, data analysis methods, and expected results, should be provided to ensure the data is used in a reasonable and effective manner. Additionally, researchers must outline data security and privacy protection measures to ensure the safe storage, transmission, and use of the data in compliance with relevant regulations and policies.

Locations

CN (1)