Nasopharyngeal CarcinomaPhase 3NCT06438627
Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial
A Phase 3 study testing TPC combined with Apatinib and Camrelizumab and GP Combined With Camrelizumab in people with Nasopharyngeal Carcinoma, run by XIANG YANQUN at 2 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- TPC combined with Apatinib and Camrelizumab and GP Combined With Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesChina
- Study dates
- 30 May 2024to 30 May 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed WHO type II or III;
- Staging TanyN3M0 (UICC/AJCC 8th edition);
- Treatment-naive patients with no history of other malignancies;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Age 18-65 years;
- Neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L, transaminases <2.5 times the upper limit of normal, total bilirubin <1.5 times the upper limit of normal, creatinine <1.5 times the upper limit of normal; activated partial thromboplastin time and international normalized ratio <1.5 times the upper limit of normal;
- Signed informed consent form.
Who cannot join
- Known or suspected allergy to the study drugs, or pregnant/perinatal women;
- Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons;
- Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance to chemoradiotherapy;
- Severe uncontrolled infection or internal medical disease;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml, exclusion if normal liver function and on antiviral medication for more than one week; hepatitis C defined as HCV-RNA above the lower limit of detection) or coinfection with hepatitis B and C;
- Factors affecting drug administration, distribution, metabolism, or excretion such as psychiatric disorders, central nervous system abnormalities, chronic diarrhea, ascites, or pleural effusion;
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- Poorly controlled hypertension despite antihypertensive treatment (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg);
- Long-term use of immunosuppressants post-organ transplantation;
- Known history of substance abuse or drug addiction;
- History of other malignancies prior to enrollment;
- Presence of other severe physical or mental illnesses or abnormal laboratory findings that may increase the risk of study participation, interfere with study results, or deemed unsuitable for participation by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 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
- Recruiting
Sun Yat sen Memorial Hospital
Guangzhou
He-Rui Yao, MD
He-Rui Yao, MD
About this study
Official title: Efficacy and Safety of Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab vs Gemcitabine, Cisplatin Combined With Camrelizumab for Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Nasopharyngeal Carcinoma: A Prospective, Controlled, Open-Label, Multicenter Phase 3 Clinical Trial
This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.
Read the detailed description
IMPORTANCE: Safe and effective therapies for untreated, advanced locally advanced nasopharyngeal carcinoma remain an unmet need.
OBJECTIVE:This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- TPC combined with Apatinib and Camrelizumab, GP Combined With Camrelizumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPC combined with Apatinib and CamrelizumabDrug
Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab
GP Combined With CamrelizumabDrug
Gemcitabine, Cisplatin regimen Combined With Camrelizumab
| Study group | Role | What they receive |
|---|---|---|
| TPC+Apatinib+Camrelizumab | Experimental | Radiation: IMRT Drug: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab (Induction chemotherapy) Receives: Drug: TPC combined with Apatinib and Camrelizumab |
| GP+ Camrelizumab | Active comparator | Radiation: IMRT Drug: Gemcitabine, Cisplatin Combined With Camrelizumab (Induction chemotherapy) Receives: Drug: GP Combined With Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years FFS
3-years failure-free survival rate
Measured: up to 3 years
Secondary outcomes (4)
DMFS
Distant metastasis-free survival rate
Measured: up to 3 years
OS
Overall survival rate
Measured: up to 3 years
LRFS
locoregional progression-free survival rate
Measured: up to 3 years
ORR
Objective response rate
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start30 May 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XIANG YANQUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XIANG YANQUN, Sun Yat-sen University
- Investigators
- Yanqun Xiang, Principal investigator, SunYat-sen U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438627
- Sponsor's protocol ID
- SYSKY-2024-267-02
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- 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 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab vs Gemcitabine, Cisplatin Combined With Camrelizumab for Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Nasopharyngeal Carcinoma: A Prospective, Controlled, Open-Label, Multicenter Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT06438627
- Acronym / sponsor ID
- SYSKY-2024-267-02
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- XIANG YANQUNUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 3 Jun 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 aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.
Detailed description
IMPORTANCE: Safe and effective therapies for untreated, advanced locally advanced nasopharyngeal carcinoma remain an unmet need.
OBJECTIVE:This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPC+Apatinib+Camrelizumab | Experimental | Drug: TPC combined with Apatinib and CamrelizumabRadiation: IMRT Drug: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab (Induction chemotherapy) |
| GP+ Camrelizumab | Active comparator | Drug: GP Combined With CamrelizumabRadiation: IMRT Drug: Gemcitabine, Cisplatin Combined With Camrelizumab (Induction chemotherapy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed WHO type II or III;
- Staging TanyN3M0 (UICC/AJCC 8th edition);
- Treatment-naive patients with no history of other malignancies;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Age 18-65 years;
Key exclusion criteria (11 listed)
- Known or suspected allergy to the study drugs, or pregnant/perinatal women;
- Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons;
- Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance to chemoradiotherapy;
- Severe uncontrolled infection or internal medical disease;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml, exclusion if normal liver function and on antiviral medication for more than one week; hepatitis C defined as HCV-RNA above the lower limit of detection) or coinfection with hepatitis B and C;
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 |
|---|---|---|
| TPC combined with Apatinib and CamrelizumabNab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab | Drug | TPC+Apatinib+Camrelizumab |
| GP Combined With CamrelizumabGemcitabine, Cisplatin regimen Combined With Camrelizumab | Drug | GP+ Camrelizumab |
Primary outcome
3-years FFS
Time frame: up to 3 years
3-years failure-free survival rate
4 secondary outcomes
DMFS
Time frame: up to 3 years
OS
Time frame: up to 3 years
LRFS
Time frame: up to 3 years
ORR
Time frame: up to 3 years
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 16 Jul 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.
Yanqun Xiang principal investigator
SunYat-sen U
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TPC combined with Apatinib and Camrelizumab and GP Combined With Camrelizumab in people with Nasopharyngeal Carcinoma, run by XIANG YANQUN at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yanqun Xiang (18666096623, xiangyq@syscc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-years FFS (time frame: up to 3 years). 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 16 Jul 2024.