Nasopharyngeal CarcinomaPhase 2NCT04221516
Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Camrelizumab in people with Nasopharyngeal Carcinoma and Oligometastasis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Oligometastasis, Radiotherapy
- What is being tested?
- Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Feb 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
About this study
Official title: Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Phase 2 Trial
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.
Read the detailed 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.
- Conditions
- Nasopharyngeal Carcinoma, Oligometastasis, Radiotherapy
- Being tested
- Camrelizumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab 200mg every 21 days (3 weeks) for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab | Experimental | Camrelizumab 200mg every 21 days for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy. Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time to progression or death from initiation of Camrelizumab
Measured: 3 years
Drug toxicity and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 years
Secondary outcomes (2)
Life Quality
Evaluate patient quality of life by EORTC QLQ-C30 scale(Scores range from 0 to 100,a high functional scale score represents a high/healthy level of functioning, while a high symptom scale score indicates a high level of symptomatology or problems)
Measured: 3 years
Overall Survival
Time to death from initiation of Camrelizumab
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Guan, Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221516
- Sponsor's protocol ID
- NFEC-2019-184
- Status last verified
- Jun 2023
- First submitted
- 6 Jan 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No