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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03930498

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted March 19, 2020

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:Recurrent Nasopharyngeal Carcinoma
  • Intervention/Treatment: Drug: PD-1 blocking antibody
    Drug: Chemotherapy
    Radiation: IMRT
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 43 participants
  • 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 2020
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: November 2022
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.

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
  • Ages Eligible for Study: 18 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

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

Locations

China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Chong Zhao, M.D Sun Yat-sen University

More Information
  • Responsible Party: Sun Yat-sen University
  • ClinicalTrials.gov Identifier: NCT03930498 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Sun Yat-sen University: Adverse effects
    PD-1 antibody
    Intensity-modulated Radiation Therapy
    Chemotherapy
    Efficacy
  • Additional relevant MeSH terms: Nasopharyngeal Carcinoma Carcinoma