Clinical trial NCT04944914: Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma
Official title: Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Oligometastatic Nasopharyngeal Carcinoma
Immunotherapy
Stereotactic Body Radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Zhongshan People's Hospital, Guangdong, China
name: Guangdong Provincial People's Hospital
First posted: 2021-06-30
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.

Detailed description: We intend to apply camrelizumab plus stereotactic body radiotherapy at oligometastatic lesions to patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical treatment through this multicenter randomized phase 3 trial to investigate whether stereotactic body radiotherapy at oligometastatic lesions on the basis of immunotherapy can achieve clinical cure among a part of patients with distant metastasis and improve their overall survival.

Eligibility criteria: Inclusion Criteria:

1. Male or female; 18-70 years of age.
2. Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
3. Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
4. Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3.
5. ECOG performance status of 0 or 1.
6. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
7. If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.):

   * Eligible if treated lesion is well controlled according to imageological examinations, and the lesion does not need stereotactic body radiotherapy.
   * If treated lesion is not controlled according to imageological examinations:

     * Eligible if the treatment is surgery and that stereotactic body radiotherapy is applicable for the treated lesion.
     * Ineligible if the treatment is radiofrequency ablation or radiotherapy.
8. Maximum diameter of brain metastatic lesion no more than 3cm.
9. Maximum diameter of metastatic lesion (brain excluded) no more than 5cm.

   * Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment.
10. Life expectancy more than 12 weeks.

Exclusion Criteria:

1. Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
2. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
3. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
4. chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
5. Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.
6. Patient with brain metastasis who needs decompression surgery.
7. Other malignancy or malignant hydrothorax.
8. Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
9. Use of large dose corticosteroids within 4 weeks before study drug administration.
10. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
11. Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
12. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.
13. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
14. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
15. Pregnancy or lactation.
16. Other ineligible patients according to attending doctor.

Primary outcomes:
measure: Median progression-free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 years
measure: Disease control rate (DCR)
timeFrame: 2 years
measure: Clinical benefit rate (CBR)
timeFrame: 2 years
measure: Median overall survival (OS)
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 year
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
timeFrame: 2 years
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
timeFrame: 2 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD, PhD
role: STUDY_CHAIR
References: