Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944914
• Other study ID #: SYSUCC-CMY-2021-
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2021
• Source: Sun Yat-sen University
• Contact: Ming-Yuan Chen, MD, PhD
• Phone: 86-20-8734-3361
• Email: chmingy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• camrelizumab
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy

Radiation:
• stereotactic body radiotherapy
Patients receive stereotactic body radiotherapy for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median progression-free survival (PFS)	Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.	2 years
Secondary	Objective response rate (ORR)	Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.	2 years
Secondary	Disease control rate (DCR)	Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.	2 years
Secondary	Clinical benefit rate (CBR)	Clinical benefit rate is the rate of patients achieving complete response, partial response or stable disease for at least 6 months after intervention.	2 years
Secondary	Median overall survival (OS)	Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened.	2 years
Secondary	Adverse events	NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.	2 year
Secondary	Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)	Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.	2 years
Secondary	Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)	Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.	2 years.