Metastatic Nasopharyngeal CarcinomaPhase 2NCT06331845
Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Gemcitabine, Cisplatin and Paclitaxel protein-bound in people with Metastatic Nasopharyngeal Carcinoma and Intermittent Systematic Chemotherapy, run by Fujian Cancer Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Nasopharyngeal Carcinoma, Intermittent Systematic Chemotherapy
- What is being tested?
- Gemcitabine, Cisplatin and Paclitaxel protein-bound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read the 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.
- Being tested
- Gemcitabine, Cisplatin, Paclitaxel protein-bound, Capecitabine, Tislelizumab
- Keywords
- metastatic nasopharyngeal carcinoma, systematic chemotherapy, intermittent systematic chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
1000 mg/m2 on Days 1 and 8
CisplatinDrug
a total of 80-100 mg/m2 for d1-3
Paclitaxel protein-boundDrug
260 mg/m2 on Day 1
CapecitabineDrug
a dose of 1-1.25 g/m2 twice daily in in 2 weeks for one cycle
TislelizumabDrug
200 mg on Day 1
| Study group | Role | What they receive |
|---|---|---|
| intermittent systematic chemotherapy group | Experimental | 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. Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Paclitaxel protein-bound; Drug: Capecitabine; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
the time interval from the start of chemotherapy to the date of progression
Measured: 1 year
Secondary outcomes (2)
progression-free survival 2
the time interval from the start of chemotherapy to the date of wide progression
Measured: 1 year
overall survival
time from the date of the start of chemotherapy to death due to any cause
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331845
- Sponsor's protocol ID
- NPC012
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06331845
- Acronym / sponsor ID
- NPC012
- Keywords
- metastatic nasopharyngeal carcinoma, systematic chemotherapy, intermittent systematic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intermittent systematic chemotherapy group | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Drug: Paclitaxel protein-bound, Drug: Capecitabine, Drug: TislelizumabPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine1000 mg/m2 on Days 1 and 8 | Drug | intermittent systematic chemotherapy group |
| Cisplatina total of 80-100 mg/m2 for d1-3 | Drug | intermittent systematic chemotherapy group |
| Paclitaxel protein-bound260 mg/m2 on Day 1 | Drug | intermittent systematic chemotherapy group |
| Capecitabinea dose of 1-1.25 g/m2 twice daily in in 2 weeks for one cycle | Drug | intermittent systematic chemotherapy group |
| Tislelizumab200 mg on Day 1 | Drug | intermittent systematic chemotherapy group |
Primary outcome
progression-free survival
Time frame: 1 year
the time interval from the start of chemotherapy to the date of progression
2 secondary outcomes
progression-free survival 2
Time frame: 1 year
overall survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Cisplatin and Paclitaxel protein-bound in people with Metastatic Nasopharyngeal Carcinoma and Intermittent Systematic Chemotherapy, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaojun Lin, DR (13860603879, linshaojun@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.