Programmed Death-1 (PD-1) Antibody Combined With IMRT in Recurrent Nasopharyngeal Carcinoma Patients

Brief Title

Programmed Death-1 (PD-1) Antibody Combined With IMRT in Recurrent Nasopharyngeal Carcinoma Patients

Official Title

PD-1 Antibody Combined With IMRT vs. IMRT in Recurrent Nasopharyngeal Carcinoma Patients: a Multi-center, Randomised Controlled, Phase III Clinical Trial

Brief Summary

      This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this
      study is to evaluate the efficacy and adverse effect of PD-1 antibody with IMRT versus IMRT
      alone in recurrent nasopharyngeal carcinoma patients.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival

Secondary Outcome

 Progression free survival

Condition

Recurrent Nasopharyngeal Carcinoma

Intervention

PD-1 blocking antibody

Study Arms / Comparison Groups

 PD-1 antibody plus IMRT

Description:  Patients randomized to this arm will receive PD-1 antibody (JS001) 240mg every three weeks during IMRT and as adjuvant therapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 1, 2020

Completion Date

July 2024

Primary Completion Date

November 2021

Eligibility 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;

          -  No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;

          -  No contraindications to immunotherapy or radiotherapy;

          -  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:

          -  Treated with anti-tumor Chinese medicine treatment;

          -  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 ≥10E4copiers/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.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Chong Zhao, 02087342638, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03907826

Organization ID

rNPC-JS001

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

Chong Zhao, Principal Investigator, Sun Yat-sen University

Verification Date

March 2020