Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma

NCT06331845 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NPC012
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).

Conditions

Metastatic Nasopharyngeal Carcinoma; Intermittent Systematic Chemotherapy

Keywords

metastatic nasopharyngeal carcinoma; systematic chemotherapy; intermittent systematic chemotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  the time interval from the start of chemotherapy to the date of progression

  1 year

Secondary Outcomes (2)

• progression-free survival 2

  1 year

• overall survival

  1 year

Study Arms (1)

intermittent systematic chemotherapy group

EXPERIMENTAL

Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.

Drug: Gemcitabine; Drug: Cisplatin; Drug: Paclitaxel protein-bound; Drug: Capecitabine; Drug: Tislelizumab

Interventions

Gemcitabine DRUG

1000 mg/m2 on Days 1 and 8

intermittent systematic chemotherapy group

Cisplatin DRUG

a total of 80-100 mg/m2 for d1-3

intermittent systematic chemotherapy group

Paclitaxel protein-bound DRUG

260 mg/m2 on Day 1

intermittent systematic chemotherapy group

Capecitabine DRUG

a dose of 1-1.25 g/m2 twice daily in in 2 weeks for one cycle

intermittent systematic chemotherapy group

Tislelizumab DRUG

200 mg on Day 1

intermittent systematic chemotherapy group

Eligibility Criteria

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

You may qualify if:

• Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases were defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥ 6 months as judged by the Investigator;
• The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Adequate organ function;
• Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
• Able and willing to provide a signed informed consent form, and able to comply with all procedures.
• The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.

You may not qualify if:

• Patients with a hypersensitivity to any of the drugs used in our study;
• With any active autoimmune disease or history of autoimmune disease;
• Clinically significant cardiovascular and cerebrovascular diseases;
• Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
• Active systemic infection;
• Drug or alcohol abuse;
• No or limited capacity for civil conduct;
• The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
• History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；
• Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and the subject requiring hormone therapy during trials.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Cisplatin; Taxes; Capecitabine; tislelizumab

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Economics; Health Care Economics and Organizations; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shaojun Lin, DR

CONTACT

13860603879; linshaojun@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 26, 2024

Record last verified: 2024-03