免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

Study Description
Brief Summary:
This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Recurrent Nasopharyngeal Carcinoma Drug: PD-1 blocking antibody Drug: Chemotherapy Radiation: IMRT Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: PD-1 antibody plus chemoradiotherapy Drug: PD-1 blocking antibody
Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
Other Name: JS001

Drug: Chemotherapy
Cisplatin and Gemcitabine

Radiation: IMRT
IMRT 60-66Gy, 1.8-2.0Gy/f/day

Outcome Measures
Primary Outcome Measures :
  1. Objective response rate [ Time Frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) ]
    Patient's short-term effect


Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) ]
    Patient's short-term effect

  2. Progression free survival [ Time Frame: 3 years ]
    From date of recruitment to disease progression

  3. Overall survival [ Time Frame: 3 years ]
    From date of recruitment to disease progression

  4. Adverse effects [ Time Frame: through study completion, an average of 3 months ]
    Evaluating with CTCAE v5.0

  5. Quality of life: EuroQoL 5 dimension [ Time Frame: through whole study, an average of 3 years ]
    Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
  • Not suitable for surgery;
  • Newly histologic diagnosis of NPC (WHO II/III);
  • Clinical stage rII-IVa (AJCC/UICC 8th);
  • ECOG 0-1 point;
  • PRANCIS score > 252 points;
  • No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
  • No contraindications to immunotherapy or chemoradiotherapy;
  • Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
  • Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
  • Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
  • Take effective contraceptions during and two months after treatment;
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • Have recurrence with local necrosis;
  • Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
  • Unexplained fever > 38.5 ℃, except for tumor fever;
  • Treated with ≥ 5 days antibiotics one month before enrollment;
  • Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
  • Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
  • Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
  • Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
  • Have known allergy to large molecule protein products or any compound of study therapy;
  • Pregnant or breastfeeding;
  • Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
  • Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
  • Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jingjing Miao, M.D 02087342638 miaojj1@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Chong Zhao, M.D    +86-13902206160    zhaochong@sysucc.org.cn   
Contact: Jingjing Miao, M.D    02087342638    miaojj@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Chong Zhao, M.D Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
Objective response rate [ Time Frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) ]
Patient's short-term effect
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Disease control rate [ Time Frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) ]
    Patient's short-term effect
  • Progression free survival [ Time Frame: 3 years ]
    From date of recruitment to disease progression
  • Overall survival [ Time Frame: 3 years ]
    From date of recruitment to disease progression
  • Adverse effects [ Time Frame: through study completion, an average of 3 months ]
    Evaluating with CTCAE v5.0
  • Quality of life: EuroQoL 5 dimension [ Time Frame: through whole study, an average of 3 years ]
    Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma
Official Title  ICMJE PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial
Brief Summary This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: PD-1 blocking antibody
    Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
    Other Name: JS001
  • Drug: Chemotherapy
    Cisplatin and Gemcitabine
  • Radiation: IMRT
    IMRT 60-66Gy, 1.8-2.0Gy/f/day
Study Arms  ICMJE Experimental: PD-1 antibody plus chemoradiotherapy
Interventions:
  • Drug: PD-1 blocking antibody
  • Drug: Chemotherapy
  • Radiation: IMRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
43
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
  • Not suitable for surgery;
  • Newly histologic diagnosis of NPC (WHO II/III);
  • Clinical stage rII-IVa (AJCC/UICC 8th);
  • ECOG 0-1 point;
  • PRANCIS score > 252 points;
  • No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
  • No contraindications to immunotherapy or chemoradiotherapy;
  • Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
  • Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
  • Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
  • Take effective contraceptions during and two months after treatment;
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • Have recurrence with local necrosis;
  • Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
  • Unexplained fever > 38.5 ℃, except for tumor fever;
  • Treated with ≥ 5 days antibiotics one month before enrollment;
  • Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
  • Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
  • Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
  • Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
  • Have known allergy to large molecule protein products or any compound of study therapy;
  • Pregnant or breastfeeding;
  • Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
  • Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
  • Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jingjing Miao, M.D 02087342638 miaojj1@sysucc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930498
Other Study ID Numbers  ICMJE High-risk rNPC-JS001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhao Chong, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chong Zhao, M.D Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP