BridgeMD
New treatment option for Nasopharyngeal Carcinoma
Official title Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT05147844
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
Also referred to as JS001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Must have signed written informed consent and able to comply with study procedure
- 18-75 years old
- Histologically or cytologically confirmed nasopharyngeal carcinoma
- Pathology or imaging confirmed metastatic nasopharyngeal carcinoma.( Clinical stage of IVB according to the 8th edition of AJCC)
- Imaging (preferred PET-CT) confirmed oligometastatic NPC (defined as ≤5 metastatic lesions, ≤2 metastatic organs)
You likely can't join if
- Allergy to any component of toripalimab
- With any active autoimmune disease or a history of autoimmune disease that may relapse Note: Patients with the following diseases were not excluded...
- Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally relapsed cancer...
- Received corticosteroid therapy at a dose ≥ 10 mg prednisone per day or any other systemic immunosuppressive therapy within 14 days prior to...
- Patient with uncontrolled diabetes, or abnormal potassium, sodium or corrected calcium levels (≥ grade 1) after receiving standard treatment, or ≥...
- Patient with a history of interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung...
See the full eligibility criteria
- Must have signed written informed consent and able to comply with study procedure
- 18-75 years old
- Histologically or cytologically confirmed nasopharyngeal carcinoma
- Pathology or imaging confirmed metastatic nasopharyngeal carcinoma.( Clinical stage of IVB according to the 8th edition of AJCC)
- Imaging (preferred PET-CT) confirmed oligometastatic NPC (defined as ≤5 metastatic lesions, ≤2 metastatic organs)
- Have not received any treatment for metastatic nasopharyngeal carcinoma.
- Unsuitable or unwilling to receive chemotherapy according to the judgment of investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1
- Estimated life ≥ 6 month
- At least 1 measurable lesions according to RECIST v1.1
- Adequate organ function, defined as achieving the following laboratory test results within 7 days before enrollment: ANC≥1.5×10\^9/L，PLT≥100×10\^9/L，Hb≥90g/L((Have not accepted blood transfusion or growth factors within...
- Allergy to any component of toripalimab
- With any active autoimmune disease or a history of autoimmune disease that may relapse Note: Patients with the following diseases were not excluded and should be further screened: Controlled type 1 diabetes...
- Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally relapsed cancer that has been cured after treatment (eg, resected basal or squamous...
- Received corticosteroid therapy at a dose ≥ 10 mg prednisone per day or any other systemic immunosuppressive therapy within 14 days prior to enrollment.
- Patient with uncontrolled diabetes, or abnormal potassium, sodium or corrected calcium levels (≥ grade 1) after receiving standard treatment, or ≥ grade 3 hypoalbuminemia within 14 days prior to enrollment
- Patient with a history of interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.
- Evidence of severe chronic or active infections (including tuberculosis infection) requiring systemic antibiotics, antibacterial or antiviral therapy within 14 days prior to enrollment
- Patient with a history of HIV infection
- Evidence of contraindications of immunotherapy or radiotherapy
- Patient with untreated chronic hepatitis B or HBV-DNA≥ 500 IU/mL, or active hepatitis C. Note: Patients with inactive infection of hepatitis B surface antigen (HBsAg), stable hepatitis B after treatment (HBV DNA \< 500...
- Have undergone any operation requiring general anesthesia within 28 days prior to enrollment
- Previous allogeneic stem cell transplantation or organ transplantation
- Patient with any of the following cardiovascular risk factors: Cardiogenic chest pain within 28 days prior to enrollment, which is defined as moderate pain that limits instrumental activities of daily life; Symptomatic...
- Grade 2 peripheral nerve disease according to NCI-CTCAE V5.0
- Underlying medical conditions (including abnormal laboratory test values) that: affect drug administration; affect the interpretation of toxicity or AE; lead to poor compliance; alcohol or drug abuse or dependence
- Participate in another treatment clinical study at the same time
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.