Actively Recruiting
The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC
Led by Chongqing University Cancer Hospital · Updated on 2024-03-28
39
Participants Needed
3
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.
CONDITIONS
Official Title
The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Male or female aged 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed metastatic or recurrent nasopharyngeal carcinoma
- At least two lesions, with at least one safely amenable to irradiation (including previously irradiated lesions if at least 6 months have passed and dose constraints are met)
- A separate measurable lesion not to be irradiated, measurable by CT or MRI per RECIST 1.1 criteria
- Peripheral blood EBV DNA copy number can be obtained
- Prior palliative or curative radiotherapy completed at least 14 days before randomization
- Immunosuppressive doses of systemic medication (e.g., steroids >10 mg/day prednisone or equivalent) discontinued at least 14 days before camrelizumab administration
- Screening laboratory values within specified limits (WBC ≥ 2 K/microliter, neutrophils ≥ 1.5 K/microliter, platelets ≥ 100 K/microliter, hemoglobin ≥ 9.0 g/dL, serum creatinine ≤ 1.5 x ULN or creatinine clearance > 40 ml/min, AST/ALT ≤ 3 x ULN, total bilirubin < 1.5 x ULN except Gilbert Syndrome allowed up to < 3.0 mg/dL)
- Resting baseline oxygen saturation ≥ 92% by pulse oximetry
- Women of childbearing potential must have a negative pregnancy test within 28 days prior to randomization and agree to contraception during and after treatment
- Men sexually active with women of childbearing potential must use effective contraception during and after treatment
- Women not of childbearing potential and azoospermic men are exempt from contraception but must have pregnancy test
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations
You will not qualify if you...
- Active brain metastases or leptomeningeal disease unless treated and stable with no progression for at least 8 weeks before study treatment
- Any medical condition that increases risk or interferes with study interpretation as judged by investigator
- Prior active malignancy within 3 years except certain locally curable cancers unless approved by principal investigator
- Systemic corticosteroids > 10 mg prednisone equivalent or other immunosuppressive medications within 14 days before study drug administration
- Positive test for hepatitis B surface antigen or hepatitis C RNA indicating acute or chronic infection
- Known HIV infection or AIDS
- Grade 4 laboratory abnormalities
- Allergy to camrelizumab components or history of severe hypersensitivity to monoclonal antibodies
- Use of immunosuppressive agents (except to treat drug-related adverse events) or concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational cancer agents during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
2
Chongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, China, 404100
Actively Recruiting
3
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Actively Recruiting
Research Team
J
Jiangdong Sui, Ph.D, M.D.
CONTACT
Y
Ying Wang, Ph.D, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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