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

NCT ID: NCT06331845

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2028-05-01

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).

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.

Conditions

Metastatic Nasopharyngeal Carcinoma; Intermittent Systematic Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intermittent systematic chemotherapy group

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1000 mg/m2 on Days 1 and 8

Cisplatin

Intervention Type: DRUG

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

Paclitaxel protein-bound

Intervention Type: DRUG

260 mg/m2 on Day 1

Capecitabine

Intervention Type: DRUG

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

Tislelizumab

Intervention Type: DRUG

200 mg on Day 1

Interventions

Gemcitabine

1000 mg/m2 on Days 1 and 8

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Paclitaxel protein-bound

260 mg/m2 on Day 1

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Tislelizumab

200 mg on Day 1

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Shaojun Lin, DR

Role: CONTACT

linshaojun@yeah.net

13860603879

Other Identifiers

NPC012

Identifier Type: -

Identifier Source: org_study_id