Nasopharyngeal Cancinoma (NPC)Phase 3NCT06669611
Nab-TPC vs GP Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing Camrelizumab combined GP chemotherapy and Camrelizumab combined TPC chemotherapy in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Camrelizumab combined GP chemotherapy and Camrelizumab combined TPC chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2024to 20 Nov 2029
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- ECOG score of 0-1.
- Expected survival of at least 12 weeks.
- Recurrent/Metastatic Nasopharyngeal Carcinoma.
- At least 4 weeks since the previous chemotherapy.
- At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions.
- had adequate organ function
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
SunYat-senU
Guangzhou, Guangdong, 510060
Yanqun Xiang, MD, +86-18666096623, xiangyq@sysucc.org.cn
Weixiong Xia, MD, +86-18520415699, xiawx@sysucc.org.cn
About this study
Official title: Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study
We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.
Read the detailed description
The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Camrelizumab combined GP chemotherapy, Camrelizumab combined TPC chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab combined GP chemotherapyDrug
Also called Camrelizumab, cisplatin and gemcitabine
Camrelizumab was intravenously given at dose of 200 mg on day 1. The GP regimen included gemcitabine administered at a dose of 1 g/m2 on day 1 and day 8, cisplatin at a dose of 80 mg/m2 on day 1.Q3W 1 cycle, 4-6 cycles.
Camrelizumab combined TPC chemotherapyDrug
Also called camrelizumab plus nab-TPC chemotherapy, nab-paclitaxel, cisplatin and capecitabine
Camrelizumab was intravenously given at dose of 200 mg on day 1. The TPC regimen included nab-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle. Q3W 1 cycle, 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab with GP chemotherapy | Active comparator | Camrelizumab, cisplatin and gemcitabine Receives: Drug: Camrelizumab combined GP chemotherapy |
| camrelizumab with nab-TPC chemotherapy | Experimental | camrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine) Receives: Drug: Camrelizumab combined TPC chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The primary endpoint was PFS, which was assessed as the time from randomization to disease progression per RECIST v1.1 assessed by IRC or death, whichever occurred first.
Measured: 15 months
Secondary outcomes (2)
Overall Survival
The secondary endpoint was OS, which was assessed as the time from randomization to death according to RECIST v1.1 or PERCIST, whichever occurred first.
Measured: 1,3,5 years
Safety and Adverse Events
Adverse events occurring during chemotherapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start27 Nov 2024
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG YANQUN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669611
- Sponsor's protocol ID
- SYSKY-2024-869-01
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT06669611
- Acronym / sponsor ID
- SYSKY-2024-869-01
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 Nov 2029 (estimated)
- First posted
- 1 Nov 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.
We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.
Detailed description
The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab with GP chemotherapy | Active comparator | Drug: Camrelizumab combined GP chemotherapyCamrelizumab, cisplatin and gemcitabine |
| camrelizumab with nab-TPC chemotherapy | Experimental | Drug: Camrelizumab combined TPC chemotherapycamrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 18 years.
- ECOG score of 0-1.
- Expected survival of at least 12 weeks.
- Recurrent/Metastatic Nasopharyngeal Carcinoma.
- At least 4 weeks since the previous chemotherapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Camrelizumab combined GP chemotherapyAlso: Camrelizumab, cisplatin and gemcitabineCamrelizumab was intravenously given at dose of 200 mg on day 1. The GP regimen included gemcitabine administered at a dose of 1 g/m2 on day 1 and day 8, cisplatin at a dose of 80 mg/m2 on day 1.Q3W 1 cycle, 4-6 cycles. | Drug | Camrelizumab with GP chemotherapy |
| Camrelizumab combined TPC chemotherapyAlso: camrelizumab plus nab-TPC chemotherapy, nab-paclitaxel, cisplatin and capecitabineCamrelizumab was intravenously given at dose of 200 mg on day 1. The TPC regimen included nab-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle. Q3W 1 cycle, 4-6 cycles. | Drug | camrelizumab with nab-TPC chemotherapy |
Primary outcome
Progression-Free Survival
Time frame: 15 months
The primary endpoint was PFS, which was assessed as the time from randomization to disease progression per RECIST v1.1 assessed by IRC or death, whichever occurred first.
2 secondary outcomes
Overall Survival
Time frame: 1,3,5 years
Safety and Adverse Events
Time frame: 3 months
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 30 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab combined GP chemotherapy and Camrelizumab combined TPC chemotherapy in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 XIANG YANQUN (02087343379, xiangyq@sysucc.org.cn), 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: 15 months). 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 30 Dec 2024.