Nasopharyngeal CarcinomaPhase 2NCT04517214
Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Toripalimab, IMRT to the nasopharynx and neck and Gemcitabine and Cisplatin Chemotherapy in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Toripalimab, IMRT to the nasopharynx and neck and Gemcitabine and Cisplatin Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2026
- 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
- Sign an informed consent;
- Age older than 18 years old and younger than 70 years old;
- Patients with newly histologically confirmed primary metastatic nasopharyngeal carcinoma;
- At least one metastatic site that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
- Anticipated overall survival more than 3 months;
- Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
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- No primary treatment of radiation, surgery, chemotherapy, targeted therapy and immune therapy post diagnosis of NPC;
- Neutrophil ≥ 1.5×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L;
- With normal liver function test (ALT、AST ≤ 3×ULN, TBIL≤ 1.5×ULN, Albumin≥2.8g/dL );
- With normal renal function test (Creatinine ≤ 1.5 ×ULN and creatinine clearance ≥60 ml/min);
- HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
- Male and no pregnant female, able to adapt birth control methods during treatment.
Who cannot join
- Hypersensitivity to Toripalimab, Gemcitabine, Cisplatin and Capecitabine;
- Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
- Necrotic disease, high-risk of massive nasal bleeding;
- Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- Receive vaccine or live vaccine within 30 days prior to signing the informed consent;
- Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
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- Severe, uncontrolled medical conditions and infections;
- Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy; vitiligo or inactive asthma who don't need systemic therapy can recruit;
- History of interstitial lung disease;
- HIV positive;
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
- Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors;
- Women of child-bearing potential who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma
The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
Read the detailed description
About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Toripalimab, IMRT to the nasopharynx and neck, Gemcitabine and Cisplatin Chemotherapy, Adjuvant chemotherapy with Capecitabine
- Keywords
- Nasopharyngeal Carcinoma, Primary metastatic, de novo metastatic, Toripalimab, PD-1, Immune checkpoint inhibitor, 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.
ToripalimabDrug
Also called JS001
PD-1 inhibitor
IMRT to the nasopharynx and neckRadiation
Also called RT to the nasopharynx and neck
IMRT to the nasopharynx and neck
Gemcitabine and Cisplatin ChemotherapyDrug
Also called GP regimen chemotherapy
Systemic chemotherapy
Adjuvant chemotherapy with CapecitabineDrug
Also called Xeloda
Adjuvant chemotherapy after radiation
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab Combined with GP Arm | Experimental | Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w Receives: Drug: Toripalimab; Radiation: IMRT to the nasopharynx and neck; Drug: Gemcitabine and Cisplatin Chemotherapy; Drug: Adjuvant chemotherapy with Capecitabine |
| GP Arm | Active comparator | Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w Receives: Radiation: IMRT to the nasopharynx and neck; Drug: Gemcitabine and Cisplatin Chemotherapy; Drug: Adjuvant chemotherapy with Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause
Measured: 5 year
Secondary outcomes (9)
Objective Response Rate of Systemic chemotherapy
ORR according to RECIST 1.1 Criteria
Measured: At the end of Cycle 6 of chemotherapy (each cycle is 21 days)
Disease Control Rate of Systemic chemotherapy
DCR according to RECIST 1.1 Criteria
Measured: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
The proportion of patients received radiotherapy to nasopharynx
Only patients with disease control after systemic chemotherapy will receive radiotherapy
Measured: 2 year
Overall Survival
Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 5 year
Progression-free Survival Rate
Defined from date of randomization to date of first documentation of progression or death due to any cause.
Measured: 1 year, 2 year rates
Overall Survival Rate
Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 1 year, 2 year rates
the Incidence of Adverse Effect
According to CTCAE 4.0.03
Measured: 1 year
Changes of Quality of life, according to EORTC QLQ-C30
According to EORTC QLQ-C30
Measured: 1 year
Changes of Quality of life, according to EORTC QLQ-H&N35
According to EORTC QLQ-H\&N35
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 posted18 Aug 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University Eye and ENT Hospital, Anhui Provincial Hospital, Sir Run Run Shaw Hospital, Hangzhou Cancer Hospital, Ningbo Medical Center Lihuili Hospital, The First People's Hospital of Changzhou, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, Shenzhen People's Hospital, First Affiliated Hospital of Xi'anJiaotong Univerisity, Guangzhou Panyu Central Hospital, Fujian Cancer Hospital
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
- Investigators
- Chaosu Hu, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517214
- Sponsor's protocol ID
- TRANSFORM
- Status last verified
- Mar 2025
- First submitted
- 31 Jul 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang F, Jin T, Feng XL, Jin QF, Chen XZ. Long-term outcomes and failure patterns of patients with nasopharyngeal carcinoma staged by magnetic resonance imaging in intensity-modulated radiotherapy era: The Zhejiang Cancer Hospital's experience. J Cancer Res Ther. 2015 Oct;11 Suppl 2:C179-84. doi: 10.4103/0973-1482.168181.
PubMed 26506872Ou X, Zhou X, Shi Q, Xing X, Yang Y, Xu T, Shen C, Wang X, He X, Kong L, Ying H, Hu C. Treatment outcomes and late toxicities of 869 patients with nasopharyngeal carcinoma treated with definitive intensity modulated radiation therapy: new insight into the value of total dose of cisplatin and radiation boost. Oncotarget. 2015 Nov 10;6(35):38381-97. doi: 10.18632/oncotarget.5420.
PubMed 26485757Lee AW, Ng WT, Chan LL, Hung WM, Chan CC, Sze HC, Chan OS, Chang AT, Yeung RM. Evolution of treatment for nasopharyngeal cancer--success and setback in the intensity-modulated radiotherapy era. Radiother Oncol. 2014 Mar;110(3):377-84. doi: 10.1016/j.radonc.2014.02.003. Epub 2014 Mar 11.
PubMed 24630534Lang J, Gao L, Guo Y, Zhao C, Zhang C; Society of Head & Neck Tumor Surgery; Society of Radiation Therapy; Chinese Anti-Cancer Association. Comprehensive treatment of squamous cell cancer of head and neck: Chinese expert consensus 2013. Future Oncol. 2014;10(9):1635-48. doi: 10.2217/fon.14.44. Epub 2014 Mar 17.
PubMed 24635574Chua MLK, Wee JTS, Hui EP, Chan ATC. Nasopharyngeal carcinoma. Lancet. 2016 Mar 5;387(10022):1012-1024. doi: 10.1016/S0140-6736(15)00055-0. Epub 2015 Aug 28.
PubMed 26321262Zou X, You R, Liu H, He YX, Xie GF, Xie ZH, Li JB, Jiang R, Liu LZ, Li L, Zhang MX, Liu YP, Hua YJ, Guo L, Qian CN, Mai HQ, Chen DP, Luo Y, Shen LF, Hong MH, Chen MY. Establishment and validation of M1 stage subdivisions for de novo metastatic nasopharyngeal carcinoma to better predict prognosis and guide treatment. Eur J Cancer. 2017 May;77:117-126. doi: 10.1016/j.ejca.2017.02.029. Epub 2017 Apr 7.
PubMed 28391025Sun XS, Liu LT, Liu SL, Guo SS, Wen YF, Xie HJ, Tang QN, Liang YJ, Li XY, Yan JJ, Ma J, Chen QY, Tang LQ, Mai HQ. Identifying optimal candidates for local treatment of the primary tumor among patients with de novo metastatic nasopharyngeal carcinoma: a retrospective cohort study based on Epstein-Barr virus DNA level and tumor response to palliative chemotherapy. BMC Cancer. 2019 Jan 21;19(1):92. doi: 10.1186/s12885-019-5281-5.
PubMed 30665378Chua DT, Sham JS, Au GK. A phase II study of docetaxel and cisplatin as first-line chemotherapy in patients with metastatic nasopharyngeal carcinoma. Oral Oncol. 2005 Jul;41(6):589-95. doi: 10.1016/j.oraloncology.2005.01.008. Epub 2005 Apr 14.
PubMed 15975521Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23.
PubMed 27567279Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10.
PubMed 30213452
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04517214
- Acronym / sponsor ID
- TRANSFORM
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Primary metastatic, de novo metastatic, Toripalimab, PD-1, Immune checkpoint inhibitor, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fudan University Eye and ENT Hospital, Anhui Provincial Hospital, Sir Run Run Shaw Hospital, Hangzhou Cancer Hospital, Ningbo Medical Center Lihuili Hospital, The First People's Hospital of Changzhou, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, Shenzhen People's Hospital, First Affiliated Hospital of Xi'anJiaotong Univerisity, Guangzhou Panyu Central Hospital, Fujian Cancer Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Aug 2020 (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.
The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
Detailed description
About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toripalimab Combined with GP Arm | Experimental | Drug: Toripalimab, Radiation: IMRT to the nasopharynx and neck, Drug: Gemcitabine and Cisplatin Chemotherapy, Drug: Adjuvant chemotherapy with CapecitabineSystemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w |
| GP Arm | Active comparator | Radiation: IMRT to the nasopharynx and neck, Drug: Gemcitabine and Cisplatin Chemotherapy, Drug: Adjuvant chemotherapy with CapecitabineSystemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign an informed consent;
- Age older than 18 years old and younger than 70 years old;
- Patients with newly histologically confirmed primary metastatic nasopharyngeal carcinoma;
- At least one metastatic site that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
- Anticipated overall survival more than 3 months;
Key exclusion criteria (13 listed)
- Hypersensitivity to Toripalimab, Gemcitabine, Cisplatin and Capecitabine;
- Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
- Necrotic disease, high-risk of massive nasal bleeding;
- Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- Receive vaccine or live vaccine within 30 days prior to signing the informed consent;
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 |
|---|---|---|
| ToripalimabAlso: JS001PD-1 inhibitor | Drug | Toripalimab Combined with GP Arm |
| IMRT to the nasopharynx and neckAlso: RT to the nasopharynx and neckIMRT to the nasopharynx and neck | Radiation | GP Arm, Toripalimab Combined with GP Arm |
| Gemcitabine and Cisplatin ChemotherapyAlso: GP regimen chemotherapySystemic chemotherapy | Drug | GP Arm, Toripalimab Combined with GP Arm |
| Adjuvant chemotherapy with CapecitabineAlso: XelodaAdjuvant chemotherapy after radiation | Drug | GP Arm, Toripalimab Combined with GP Arm |
Primary outcome
Progression-free survival
Time frame: 5 year
PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause
9 secondary outcomes
Objective Response Rate of Systemic chemotherapy
Time frame: At the end of Cycle 6 of chemotherapy (each cycle is 21 days)
Disease Control Rate of Systemic chemotherapy
Time frame: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
The proportion of patients received radiotherapy to nasopharynx
Time frame: 2 year
Overall Survival
Time frame: 5 year
Progression-free Survival Rate
Time frame: 1 year, 2 year rates
Overall Survival Rate
Time frame: 1 year, 2 year rates
the Incidence of Adverse Effect
Time frame: 1 year
Changes of Quality of life, according to EORTC QLQ-C30
Time frame: 1 year
Changes of Quality of life, according to EORTC QLQ-H&N35
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 2 Apr 2025.
- Background: PubMed 26506872Jiang F, Jin T, Feng XL, Jin QF, Chen XZ. Long-term outcomes and failure patterns of patients with nasopharyngeal carcinoma staged by magnetic resonance imaging in intensity-modulated radiotherapy era: The Zhejiang Cancer Hospital's experience. J Cancer Res Ther. 2015 Oct;11 Suppl 2:C179-84. doi: 10.4103/0973-1482.168181.
- Background: PubMed 26485757Ou X, Zhou X, Shi Q, Xing X, Yang Y, Xu T, Shen C, Wang X, He X, Kong L, Ying H, Hu C. Treatment outcomes and late toxicities of 869 patients with nasopharyngeal carcinoma treated with definitive intensity modulated radiation therapy: new insight into the value of total dose of cisplatin and radiation boost. Oncotarget. 2015 Nov 10;6(35):38381-97. doi: 10.18632/oncotarget.5420.
- Background: PubMed 24630534Lee AW, Ng WT, Chan LL, Hung WM, Chan CC, Sze HC, Chan OS, Chang AT, Yeung RM. Evolution of treatment for nasopharyngeal cancer--success and setback in the intensity-modulated radiotherapy era. Radiother Oncol. 2014 Mar;110(3):377-84. doi: 10.1016/j.radonc.2014.02.003. Epub 2014 Mar 11.
- Background: PubMed 24635574Lang J, Gao L, Guo Y, Zhao C, Zhang C; Society of Head & Neck Tumor Surgery; Society of Radiation Therapy; Chinese Anti-Cancer Association. Comprehensive treatment of squamous cell cancer of head and neck: Chinese expert consensus 2013. Future Oncol. 2014;10(9):1635-48. doi: 10.2217/fon.14.44. Epub 2014 Mar 17.
- Background: PubMed 26321262Chua MLK, Wee JTS, Hui EP, Chan ATC. Nasopharyngeal carcinoma. Lancet. 2016 Mar 5;387(10022):1012-1024. doi: 10.1016/S0140-6736(15)00055-0. Epub 2015 Aug 28.
- Background: PubMed 28391025Zou X, You R, Liu H, He YX, Xie GF, Xie ZH, Li JB, Jiang R, Liu LZ, Li L, Zhang MX, Liu YP, Hua YJ, Guo L, Qian CN, Mai HQ, Chen DP, Luo Y, Shen LF, Hong MH, Chen MY. Establishment and validation of M1 stage subdivisions for de novo metastatic nasopharyngeal carcinoma to better predict prognosis and guide treatment. Eur J Cancer. 2017 May;77:117-126. doi: 10.1016/j.ejca.2017.02.029. Epub 2017 Apr 7.
- Background: PubMed 30665378Sun XS, Liu LT, Liu SL, Guo SS, Wen YF, Xie HJ, Tang QN, Liang YJ, Li XY, Yan JJ, Ma J, Chen QY, Tang LQ, Mai HQ. Identifying optimal candidates for local treatment of the primary tumor among patients with de novo metastatic nasopharyngeal carcinoma: a retrospective cohort study based on Epstein-Barr virus DNA level and tumor response to palliative chemotherapy. BMC Cancer. 2019 Jan 21;19(1):92. doi: 10.1186/s12885-019-5281-5.
- Background: PubMed 15975521Chua DT, Sham JS, Au GK. A phase II study of docetaxel and cisplatin as first-line chemotherapy in patients with metastatic nasopharyngeal carcinoma. Oral Oncol. 2005 Jul;41(6):589-95. doi: 10.1016/j.oraloncology.2005.01.008. Epub 2005 Apr 14.
- Background: PubMed 27567279Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23.
- Background: PubMed 30213452Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10.
- 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. This study is not recruiting at the moment.
Chaosu Hu, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, IMRT to the nasopharynx and neck and Gemcitabine and Cisplatin Chemotherapy in people with Nasopharyngeal Carcinoma, run by Fudan 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 12 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517214, which also lists 10 linked publications.
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 Apr 2025.