Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

NCT05147844 | Recruiting Phase 2

• 1 other identifier: XQonc-017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival rate according to RECIST v1.1

  To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by 1-year progression-free survival rate according to RECIST v1.1

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. 1 year

Secondary Outcomes (9)

• PFS according to RECIST v1.1

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

• OS

  up to 5 years

• 2-year progression-free survival rate according to RECIST v1.1

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

• 2-year overall survival

  From date of randomization until death, loss to follow-up, or study termination by the Sponsor whichever occurs first.Up to 3.5 approximately years

• 1-year progression-free survival rate according to irRECIST

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately year

Study Arms (1)

Toripalimab +Radiotherapy

EXPERIMENTAL

Drug: Toripalimab

Interventions

Toripalimab DRUG

Toripalimab: 240mg, iv. Q3W for 1 year or until disease progression/intolerable toxicity Radiotherapy: Newly diagnosed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 70 Gy, pGTVnd 99Gy, pCTV1, 60 Gy, pCTV2, 54 Gy, 33 times, completed in 7 weeks. Relapsed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 60Gy, pGTVnd 60Gy, 20-25 times, completed in 4-5 weeks. Newly diagnosed and relapsed patients: SBRT for oligometastatic lesions, pGTV 25-40 Gy, 3-5 times, completed in 1-2 weeks.

Also known as: JS001

Toripalimab +Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have signed written informed consent and able to comply with study procedure
• 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 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);

You may not qualify 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 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
• 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)
• 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 IU/mL）and cured hepatitis C could be included.
• Have undergone any operation requiring general anesthesia within 28 days prior to enrollment
• Previous allogeneic stem cell transplantation or organ transplantation

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• Southwest Hospital, China: collaborator
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator
• Chongqing University Cancer Hospital: collaborator

Study Sites (2)

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director physician

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)