Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma

Last updated: June 14, 2023
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Nasopharyngeal Cancer

Carcinoma

Cancer Treatment

Treatment

Camrelizumab

Clinical Study ID

NCT04221516
NFEC-2019-184
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to see how well the experimental drug camrelizumab(SHR-1210) works in people with oligometastatic NPC who have already had locally radiotherapy for their disease. All patients will receive 200 mg of camrelizumab intravenously on Day 1 of each 21-day cycle. Patients will receive the study drug for up to 18 cycles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically confirmed non-keratinizing (according to World HealthOrganization (WHO) histologically type).
  • Patients with oligometastatic NPC (defined as ≤5 metastases, ≤2 organs), without localrecurrence of nasopharynx.
  • Completion of radiotherapy 4-12 weeks prior to enrollment. At list one cycle ofadjuvant platinum-based chemotherapy.
  • Satisfactory performance status: Karnofsky scale (KPS) > 70.
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥50 ml/min.
  • Expected lifetime over 3 months
  • Patients must be informed of the investigational nature of this study and give writteninformed consent.

Exclusion

Exclusion Criteria:

  • Previous history of autoimmune disease or unstable autoimmune disease.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, insitu cervical cancer.
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CytotoxicT-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any otherantibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Active autoimmune disease requiring systemic treatment within the past 3 months or adocumented history of clinically severe autoimmune disease, or a syndrome thatrequires systemic steroids or immunosuppressive agents. Subjects with vitiligo orresolved childhood asthma/atopy are an exception to this rule. Subjects that requireintermittent use of bronchodilators or local steroid injections are not excluded fromthe study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen'ssyndrome are not excluded from the study.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect thecompliance of the trial, for example, unstable cardiac disease requiring treatment,renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Camrelizumab
Phase: 2
Study Start date:
January 01, 2020
Estimated Completion Date:
February 01, 2024

Study Description

Each subject included in this project must sign an informed consent form. Within 4-6 weeks after completing radiotherapy and chemotherapy for oligometastatic lesions, subjects will receive camrelizumab 200 mg fixed-dose treatment every three-week (Q3W).

If there is no confirmed disease progression, unacceptable adverse events or concurrent diseases (need further treatment ), the researcher decides to withdraw from the subject, the subject withdraws from treatment, the subject is pregnant, and other reasons that do not meet the requirements of the trial treatment or procedure, The treatment with camrelizumab will last at least 12 months. Patients with no signs of disease progression can be treated with another 6 to 12 months by the decision of researcher.

After treatment, each subject will be followed up. Subjects should be monitored for adverse events for at least 30 days, and serious adverse events will be over 90 days. Subjects will be followed up 5 years from the last treatment or until one of the following events: ① disease progression; ② receive other treatments of cancer; ③ withdraw research consent; ④ loss of follow-up; ⑤ death.

Connect with a study center

  • Southern medical university

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

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