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

NCT04944914 | Recruiting Phase 3 DMC

• 1 other identifier: SYSUCC-CMY-2021-
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Oligometastatic Nasopharyngeal Carcinoma; Immunotherapy; Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Objective response rate (ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Clinical benefit rate (CBR)

  2 years

• Median overall survival (OS)

  2 years

• Adverse events

  2 year

Study Arms (2)

Camrelizumab Plus Stereotactic Body Radiotherapy

EXPERIMENTAL

Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.

Drug: camrelizumab; Radiation: stereotactic body radiotherapy

Camrelizumab

ACTIVE COMPARATOR

Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.

Drug: camrelizumab

Interventions

camrelizumab DRUG

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

Camrelizumab; Camrelizumab Plus Stereotactic Body Radiotherapy

stereotactic body radiotherapy RADIATION

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.

Also known as: SBRT

Camrelizumab Plus Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female; 18-70 years of age.
• Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
• Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
• 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.
• ECOG performance status of 0 or 1.
• Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
• 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.
• Maximum diameter of brain metastatic lesion no more than 3cm.
• 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.
• Life expectancy more than 12 weeks.

You may not qualify if:

• Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
• CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
• History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
• chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
• Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.
• Patient with brain metastasis who needs decompression surgery.
• Other malignancy or malignant hydrothorax.
• Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
• Use of large dose corticosteroids within 4 weeks before study drug administration.
• Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
• Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
• 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.
• 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.
• Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
• Pregnancy or lactation.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Guangdong Provincial People's Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; Radiosurgery

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ming-Yuan Chen, MD, PhD

  Sun Yat-Sen University Cancer Center

  STUDY CHAIR

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-20-8734-3361; chmingy@mail.sysu.edu.cn

Rui You, MD, PhD

CONTACT

86-13580439820; yourui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief physician

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2025-06

Locations

CN (1)