- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517214
Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma
July 25, 2021 updated by: Chaosu Hu, Fudan University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Interventional
Enrollment (Anticipated)
126
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chaosu Hu, M.D.
- Phone Number: 81400 +8621-64175590
- Email: hucsu62@163.com
Study Contact Backup
- Name: Xiaomin Ou, M.D.
- Phone Number: +8621-18017317872
- Email: 0456218@fudan.edu.cn
Study Locations
-
-
-
Shanghai, China, 200032
- Recruiting
- Xiaomin Ou
-
Contact:
- Xiaomin Ou, M.D.
- Phone Number: 81400 +8621-64175590
- Email: 0456218@fudan.edu.cn
-
Principal Investigator:
- Chaosu Hu, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Toripalimab Combined with GP Arm
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
|
PD-1 inhibitor
Other Names:
IMRT to the nasopharynx and neck
Other Names:
Systemic chemotherapy
Other Names:
Adjuvant chemotherapy after radiation
Other Names:
|
ACTIVE_COMPARATOR: GP Arm
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
|
IMRT to the nasopharynx and neck
Other Names:
Systemic chemotherapy
Other Names:
Adjuvant chemotherapy after radiation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate of Systemic chemotherapy
Time Frame: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
|
ORR according to RECIST 1.1 Criteria
|
At the end of Cycle 6 of chemotherapy (each cycle is 21days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate of Systemic chemotherapy
Time Frame: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
|
DCR according to RECIST 1.1 Criteria
|
At the end of Cycle 6 of chemotherapy (each cycle is 21days)
|
The proportion of patients received radiotherapy to nasopharynx
Time Frame: 2 year
|
Only patients with disease control after systemic chemotherapy will receive radiotherapy
|
2 year
|
Progression-free Survival
Time Frame: 5 year
|
Defined from date of randomization to date of first documentation of progression or death due to any cause.
|
5 year
|
Overall Survival
Time Frame: 5 year
|
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.
|
5 year
|
Progression-free Survival Rate
Time Frame: 1 year, 2 year rates
|
Defined from date of randomization to date of first documentation of progression or death due to any cause.
|
1 year, 2 year rates
|
Overall Survival Rate
Time Frame: 1 year, 2 year rates
|
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.
|
1 year, 2 year rates
|
the Incidence of Adverse Effect
Time Frame: 1 year
|
According to CTCAE 4.0.03
|
1 year
|
Changes of Quality of life, according to EORTC QLQ-C30
Time Frame: 1 year
|
According to EORTC QLQ-C30
|
1 year
|
Changes of Quality of life, according to EORTC QLQ-H&N35
Time Frame: 1 year
|
According to EORTC QLQ-H&N35
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chaosu Hu, M.D., Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ou 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.
- Lee 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.
- Lang 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.
- Chua 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.
- Zou 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.
- Sun 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.
- Chua 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.
- Zhang 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. Erratum In: Lancet. 2016 Oct 15;388(10054):1882.
- Fang 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2020
Primary Completion (ANTICIPATED)
December 31, 2024
Study Completion (ANTICIPATED)
December 31, 2026
Study Registration Dates
First Submitted
July 31, 2020
First Submitted That Met QC Criteria
August 15, 2020
First Posted (ACTUAL)
August 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 30, 2021
Last Update Submitted That Met QC Criteria
July 25, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
- Capecitabine
Other Study ID Numbers
- TRANSFORM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasopharyngeal Carcinoma
-
National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Metastatic Nasopharyngeal Nonkeratinizing Carcinoma | Metastatic Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal... and other conditionsUnited States, Canada, China, Singapore
-
National Cancer Institute (NCI)CompletedRecurrent Nasopharynx Carcinoma | Stage III Nasopharyngeal Carcinoma AJCC v7 | Stage IV Nasopharyngeal Carcinoma AJCC v7 | Stage IVA Nasopharyngeal Carcinoma AJCC v7 | Stage IVB Nasopharyngeal Carcinoma AJCC v7 | Stage IVC Nasopharyngeal Carcinoma AJCC v7 | Nasopharyngeal Nonkeratinizing CarcinomaUnited States, Singapore, China
-
National Cancer Institute (NCI)Radiation Therapy Oncology GroupCompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal...United States, Canada
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing... and other conditionsUnited States, Canada, Australia
-
Alain AlgaziAstraZeneca; Incyte CorporationWithdrawnRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma | Epstein-Barr Virus Positive | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma
-
Alliance for Clinical Trials in OncologyNot yet recruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma
-
National Cancer Institute (NCI)Not yet recruitingStage IV Nasopharyngeal Carcinoma AJCC v8 | Stage II Nasopharyngeal Carcinoma AJCC v8 | Stage III Nasopharyngeal Carcinoma AJCC v8
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownLOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNTFrance
-
Stanford UniversityTerminatedStage IV Nasopharyngeal Carcinoma | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma | Stage II Nasopharyngeal Carcinoma | Stage 0 Nasopharyngeal Carcinoma | Stage 0 Paranasal Sinus Cancer | Stage I Nasopharyngeal Carcinoma | Stage I Paranasal... and other conditionsUnited States
-
Cancer Institute and Hospital, Chinese Academy...RecruitingRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaChina
Clinical Trials on Toripalimab
-
Mabwell (Shanghai) Bioscience Co., Ltd.Not yet recruitingAdvanced Urothelial CarcinomaChina
-
Henan Cancer HospitalUnknownEsophageal Squamous Cell Carcinoma
-
Sun Yat-sen UniversityThe First Affiliated Hospital of Guangzhou Medical University; Guangzhou Panyu...RecruitingStudy of Toripalimab for Limited-Stage Small Cell Lung Cancer Following Concurrent ChemoradiotherapySmall Cell Lung Cancer Limited StageChina
-
Tianjin Medical University Cancer Institute and...Not yet recruiting
-
Qianfoshan HospitalRecruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHead and Neck Squamous Cell CarcinomasChina
-
Shanghai Junshi Bioscience Co., Ltd.Not yet recruitingMelanoma | Breast Cancer | Lung CanceChina
-
Zhejiang Genfleet Therapeutics Co., Ltd.CompletedAdvanced Solid TumorChina, Australia
-
Fudan UniversityUnknownMelanoma Stage IIIB-IVChina
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingLimited-stage Small Cell Lung Cancer (LS-SCLC)China, Taiwan, Georgia, United States