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Trial Title:
Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma
NCT ID:
NCT06331845
Condition:
Metastatic Nasopharyngeal Carcinoma
Intermittent Systematic Chemotherapy
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Paclitaxel
Gemcitabine
Capecitabine
Tislelizumab
Albumin-Bound Paclitaxel
Conditions: Keywords:
metastatic nasopharyngeal carcinoma
systematic chemotherapy
intermittent systematic chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000 mg/m2 on Days 1 and 8
Arm group label:
intermittent systematic chemotherapy group
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
a total of 80-100 mg/m2 for d1-3
Arm group label:
intermittent systematic chemotherapy group
Intervention type:
Drug
Intervention name:
Paclitaxel protein-bound
Description:
260 mg/m2 on Day 1
Arm group label:
intermittent systematic chemotherapy group
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
a dose of 1-1.25 g/m2 twice daily in in 2 weeks for one cycle
Arm group label:
intermittent systematic chemotherapy group
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200 mg on Day 1
Arm group label:
intermittent systematic chemotherapy group
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial
entry, and life expectancy ≥ 6 months as judged by the Investigator;
3. 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;
4. Take adequate contraceptive measures throughout the study, and contraception
continues until 12 months after treatment;
5. Able and willing to provide a signed informed consent form, and able to comply with
all procedures.
6. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6
months.
Exclusion Criteria:
1. Patients with a hypersensitivity to any of the drugs used in our study;
2. With any active autoimmune disease or history of autoimmune disease;
3. Clinically significant cardiovascular and cerebrovascular diseases;
4. Have or are suffering from other malignant tumors within 5 years (except
non-melanoma skin cancer or pre-invasive cervical cancer);
5. Active systemic infection;
6. Drug or alcohol abuse;
7. No or limited capacity for civil conduct;
8. 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;
9. 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；
10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before
the study treatment, and the subject requiring hormone therapy during trials.
11. Pregnancy or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331845
