Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma

NCT05431764 | Recruiting Phase 2 DMC

• 1 other identifier: SYSUCC-SBRT2022
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance regimen. To investigate the efficacy and safety of "whole target" radiotherapy combined with immuno-maintenance therapy.

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

• Median overall survival (OS)

  2 years

• Adverse events

  2 years

• Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

  2 years

Study Arms (1)

Camrelizumab Plus Stereotactic Body Radiotherapy

EXPERIMENTAL

Patients were treated with gemcitabine, cisplatin and camrelizumab for 6 cycles, followed by whole-target radiotherapy (IMRT for locoregional lesion and SBRT for oligometastatic lesions) and camrelizumab maintenance therapy.

Drug: Camrelizumab, gemcitabin, cisplatin; Radiation: Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy

Interventions

Camrelizumab, gemcitabin, cisplatin DRUG

Patients receive gemcitabine (1000 mg/m² d1,8), cisplatin (80mg/m² d1), and camrelizumab (200mg, iv drip for over 60min) every 3 weeks for 6 cycles before locoregional radiotherapy.

Also known as: PD-1 inhibitor

Camrelizumab Plus Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy RADIATION

IMRT: 5 fractions per week for 6 weeks to a total dose of 70 Gy and 33 fractions to the primary tumor. SBRT: 3 months after locoregional IMRT, patients receive SBRT 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. Camrelizumab (200mg, iv drip for over 60min) every 2 weeks began on the first day of IMRT until an intolerable toxicity, or disease progression, or withdrawal of consent, or the investigator determines that he or she has to withdraw from treatment, or has been treated for up to 2 years.

Also known as: SBRT, IMRT

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.
• Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).
• Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial.
• Patients evaluated to have a partial response (PR) or stable disease (SD) by head and neck MRI and PET/CT after 3 months of locoregional radiotherapy, and the metastatic lesions were assessed as oligometastatic lesions (the number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3).
• Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
• ECOG performance status of 0 or 1.
• 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 6 months.

You may not qualify if:

• 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.
• CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
• 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.
• Other ineligible patients according to attending doctor.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; Gemcitabine; Cisplatin; Immune Checkpoint Inhibitors; Radiosurgery; Radiotherapy, Intensity-Modulated

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Ming-Yuan Chen, MD, PhD

  Sun Yat-sen University

  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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor & chief physician

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: June 20, 2022
• Primary Completion: June 20, 2025
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

CN (1)