Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

Launched by XINQIAO HOSPITAL OF CHONGQING · Nov 23, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a medication called toripalimab in combination with radiotherapy to treat a specific type of cancer known as nasopharyngeal carcinoma (NPC) that has spread but is still limited to a few areas in the body, a condition referred to as oligometastatic NPC. The goal is to see how effective and safe this treatment approach is for patients who have not yet received any treatment for their metastatic NPC.

To participate in this trial, patients should be between 18 and 75 years old, have a confirmed diagnosis of nasopharyngeal carcinoma with limited spread (no more than five metastatic lesions), and must be in good overall health as determined by their doctor. Participants will need to provide written consent and undergo some tests to ensure they can safely take part in the study. Those who join can expect to receive toripalimab and radiotherapy while being closely monitored for any side effects and response to treatment. This trial is currently recruiting participants, so it could be a potential opportunity for those looking for new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must have signed written informed consent and able to comply with study procedure
• • 2. 18-75 years old
• • 3. Histologically or cytologically confirmed nasopharyngeal carcinoma
• • 4. Pathology or imaging confirmed metastatic nasopharyngeal carcinoma.( Clinical stage of IVB according to the 8th edition of AJCC)
• • 5. Imaging (preferred PET-CT) confirmed oligometastatic NPC (defined as ≤5 metastatic lesions, ≤2 metastatic organs)
• • 6. Have not received any treatment for metastatic nasopharyngeal carcinoma.
• • 7. Unsuitable or unwilling to receive chemotherapy according to the judgment of investigator.
• • 8. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1
• • 9. Estimated life ≥ 6 month
• • 10. At least 1 measurable lesions according to RECIST v1.1
• • 11. 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 14 days)；the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time(APTT) ≤1.5 × ULN；serum creatinine≤1.5×ULN or estimated glomerular filtration rate(GFR) ≥ 60 mL/min/1.73 m2; total bilirubin≤1.5×ULN（total bilirubin\<3×ULN for patients with Gilbert syndrome）; AST and ALT ≤ 2.5×ULN (AST and ALT ≤ 2.5×ULN for patients with liver metastasis);
• Exclusion Criteria:
• • 1. Allergy to any component of toripalimab
• • 2. 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; Hypothyroidism (could be controlled just by hormone replacement therapy); Controlled celiac disease; Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia); Any other disease which is not expected to be relapsed without external stimulate
• • 3. 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 cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
• • 4. Received corticosteroid therapy at a dose ≥ 10 mg prednisone per day or any other systemic immunosuppressive therapy within 14 days prior to enrollment.
• • 5. 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
• • 6. Patient with a history of interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.
• • 7. Evidence of severe chronic or active infections (including tuberculosis infection) requiring systemic antibiotics, antibacterial or antiviral therapy within 14 days prior to enrollment
• • 8. Patient with a history of HIV infection
• • 9. Evidence of contraindications of immunotherapy or radiotherapy
• • 10. 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 IU/mL）and cured hepatitis C could be included.
• • 11. Have undergone any operation requiring general anesthesia within 28 days prior to enrollment
• • 12. Previous allogeneic stem cell transplantation or organ transplantation
• • 13. 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 pulmonary embolism within 28 days prior to enrollment; Acute myocardial infarction within 6 months prior to enrollment; Grade III or IV disease according to the New York Heart Association within 6 months prior to enrollment;≥ Grade 2 ventricular arrhythmias within 6 months prior to enrollment or the first administration; With a history of cerebrovascular accident within 6 months prior to enrollment or the first administration
• • 14. Grade 2 peripheral nerve disease according to NCI-CTCAE V5.0
• • 15. 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
• • 16. Participate in another interventional clinical study at the same time