Metastatic Nasopharyngeal CarcinomaPhase 2NCT05484375
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment
A Phase 2 study testing Capecitabine plus toripalimab in people with Metastatic Nasopharyngeal Carcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Trial summary
to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- Capecitabine plus toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2029
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
- Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
- Age ≥18 years and ≤65 years
- WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
- With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
- With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
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- ECOG score is 0-1
- At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
- Life expectancy is at least 12 weeks
- Patients sign informed consent forms
Who cannot join
- History of severe anaphylaxis to any component of capecitabine or toripalimab
- Active or untreated central nervous system metastases
- Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
- Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
- Patients with poorly controlled or symptomatic hypercalcemia
- Pregnancy or lactation
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- Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
- Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
- History of autoimmune diseases
- Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
- Receive any active vaccine within 4 weeks prior to enrollment
- Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
- Active pneumonia
- Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
- Presence of severe neurological or psychiatric disorders, including dementia and seizures.
- Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
- Major cardiovascular diseases
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: Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study
to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.
Read the detailed description
This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
- Conditions
- Metastatic Nasopharyngeal Carcinoma
- Being tested
- Capecitabine plus toripalimab
- Keywords
- nasopharyngeal carcinoma, capecitabine, toripalimab, maintenance therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine plus toripalimabDrug
Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine plus toripalimab maintenance therapy | Experimental | capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached. Receives: Drug: Capecitabine plus toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival(PFS)
The time is defined from the enrolment to progression or death from any cause
Measured: up to 24 month
Secondary outcomes (5)
overall survival(OS)
The time is defined from the enrolment to death from any cause
Measured: up to 24 month
Objective Response Rate(ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Measured: up to 24 month
Disease Control Rate (DCR)
The proportion of patients who have achieved complete response，partial response and Stable disease assessed by investigators according to Recist v 1.1
Measured: up to 24 month
Duration of Response (DoR)
The time is defined from first documented objective response to radiographic disease progression or death, whichever occurred first, assessed by investigator
Measured: up to 24 month
Adverse Events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Measured: up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Cancer Hospital
- Responsible party
- Principal investigator, Wenjing Yin, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Investigators
- Yin Wen-Jing, Study director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484375
- Sponsor's protocol ID
- IIT-2022-017(FL5)
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2022
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05484375
- Acronym / sponsor ID
- IIT-2022-017(FL5)
- Conditions
- Metastatic Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, capecitabine, toripalimab, maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Cancer Hospital
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Aug 2022 (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.
to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.
Detailed description
This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine plus toripalimab maintenance therapy | Experimental | Drug: Capecitabine plus toripalimabcapecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
- Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
- Age ≥18 years and ≤65 years
- WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
- With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
Key exclusion criteria (17 listed)
- History of severe anaphylaxis to any component of capecitabine or toripalimab
- Active or untreated central nervous system metastases
- Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
- Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
- Patients with poorly controlled or symptomatic hypercalcemia
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 |
|---|---|---|
| Capecitabine plus toripalimabCapecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks | Drug | Capecitabine plus toripalimab maintenance therapy |
Primary outcome
progression-free survival(PFS)
Time frame: up to 24 month
The time is defined from the enrolment to progression or death from any cause
5 secondary outcomes
overall survival(OS)
Time frame: up to 24 month
Objective Response Rate(ORR)
Time frame: up to 24 month
Disease Control Rate (DCR)
Time frame: up to 24 month
Duration of Response (DoR)
Time frame: up to 24 month
Adverse Events (AEs)
Time frame: up to 24 month
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 2 Aug 2022.
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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.
Yin Wen-Jing study director
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine plus toripalimab in people with Metastatic Nasopharyngeal Carcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
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 10 inclusion and 17 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 2 Aug 2022. 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 Yin Wen-Jing (0086-13929503157, wenjing1342@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival(PFS) (time frame: up to 24 month). 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 2 Aug 2022.