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

Metastatic Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06331845
• Other study ID #: NPC012
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: March 2024
• Source: Fujian Cancer Hospital
• Contact: Shaojun Lin, DR
• Phone: 13860603879
• Email: linshaojun[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	the time interval from the start of chemotherapy to the date of progression	1 year
Secondary	progression-free survival 2	the time interval from the start of chemotherapy to the date of wide progression	1 year
Secondary	overall survival	time from the date of the start of chemotherapy to death due to any cause	1 year