Camrelizumab treatment for patients with oligometastatic nasopharyngeal carcinoma after radiotherapy
Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Phase 2 Trial
This study is testing if an experimental drug called camrelizumab can help patients with a specific type of nasopharyngeal cancer feel better after they have completed radiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | ipilimumab, chemotherapy, camrelizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04221516 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of camrelizumab, an experimental drug, in patients with oligometastatic nasopharyngeal carcinoma (NPC) who have completed radiotherapy. Participants will receive a fixed dose of 200 mg of camrelizumab intravenously every three weeks for up to 18 cycles, starting 4-6 weeks after their radiotherapy. The study aims to monitor the patients for disease progression and adverse events over a follow-up period of five years. The goal is to determine the safety and efficacy of this treatment in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed non-keratinizing oligometastatic NPC who have completed radiotherapy and adjuvant chemotherapy.
Not a fit: Patients with a history of autoimmune diseases or those who do not meet the specified health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with oligometastatic NPC, potentially improving survival rates and quality of life.
How similar studies have performed: While there have been studies on immunotherapy for various cancers, the specific use of camrelizumab for oligometastatic NPC is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). * Patients with oligometastatic NPC (defined as ≤5 metastases, ≤2 organs), without local recurrence of nasopharynx. * Completion of radiotherapy 4-12 weeks prior to enrollment. At list one cycle of adjuvant 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 written informed consent. Exclusion Criteria: * Previous history of autoimmune disease or unstable autoimmune disease. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). * Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome are not excluded from the study. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance 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.
Where this trial is running
Guangzhou, Guangdong
- Southern medical university — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jian Guan, Ph.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Jian Guan, Ph.D.
- Email: 51643930@qq.com
- Phone: +86-13632102247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.