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Not yet recruiting NCT06331845

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

Phase II Interventional Metastatic Nasopharyngeal Carcinoma Intermittent Systematic Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gemcitabine, Cisplatin, Paclitaxel protein-bound, Capecitabine.
Who it may be relevant to
Registry conditions: Metastatic Nasopharyngeal Carcinoma, Intermittent Systematic Chemotherapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Stop and go Strategy as First-line Treatment in Patients With Objective Response After Systematic Chemotherapy for Widely de Novo Metastatic Nasopharyngeal Carcinoma: A Phase II Trial

Overview

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).

Detailed description

Widely metastatic nasopharyngeal carcinoma (wmNPC) represented a particular subgroup of patients with the worst prognosis, of which palliative systematic chemotherapy(SC) was recommended as initial treatment, however, palliative systematic treatment was often required to be stopped due to the cumulative toxicities while stopping SC may lead to disease progression, a 'stop and go' approach, namely chemotherapy 'holidays', was a new strategy which may keep a good balance of benefit and risk. This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in wmNPC patients who achieve objective response after SC.

Interventions

  • Drug Gemcitabine
    1000 mg/m2 on Days 1 and 8
  • Drug Cisplatin
    a total of 80-100 mg/m2 for d1-3
  • Drug Paclitaxel protein-bound
    260 mg/m2 on Day 1
  • Drug Capecitabine
    a dose of 1-1.25 g/m2 twice daily in in 2 weeks for one cycle
  • Drug Tislelizumab
    200 mg on Day 1

Primary outcome measures

  • progression-free survival [Time frame: 1 year]
Secondary outcome measures (2)
  • progression-free survival 2 [Time frame: 1 year]
  • overall survival [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06331845 · NPC012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗