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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930498
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University

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

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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 : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930498


Contacts
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Contact: Jingjing Miao, M.D 02087342638 miaojj1@sysucc.org.cn

Locations
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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
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Principal Investigator: Chong Zhao, M.D Sun Yat-sen University
Additional Information:
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Responsible Party: Zhao Chong, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03930498    
Other Study ID Numbers: High-risk rNPC-JS001
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao Chong, Sun Yat-sen University:
PD-1 antibody
Intensity-modulated Radiation Therapy
Chemotherapy
Efficacy
Adverse effects
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antibodies
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs