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

ConditionsMetastatic Nasopharyngeal CarcinomaIntermittent Systematic Chemotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Cancer Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Gemcitabine

    Drug

    1000 mg/m2 on Days 1 and 8

  • Cisplatin

    Drug

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

  • Paclitaxel protein-bound

    Drug

    260 mg/m2 on Day 1

  • Capecitabine

    Drug

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

  • Tislelizumab

    Drug

    200 mg on Day 1

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: intermittent systematic chemotherapy groupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

progression-free survival

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

Time frame
1 year

Secondary outcomes

1

progression-free survival 2

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

Time frame
1 year
2

overall survival

time from the date of the start of chemotherapy to death due to any cause

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: