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

NCT ID: NCT05431764

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2026-06-20

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.

Detailed Description

This exploratory clinical trial will evaluate tumor control rate, survival, and safety of newly diagnosed distant metastatic nasopharyngeal carcinoma by further adding local regional IMRT, distant metastatic SBRT and immuno-maintenance therapy to the standard regimen of gemcitabine+ cisplatin+ PD-1 inhibitor (historical data). To explore whether the "full target" model can be a better comprehensive therapy for the initial diagnosed distant metastatic nasopharyngeal carcinoma in the era of immunotherapy.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab Plus Stereotactic Body Radiotherapy

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.

Group Type: EXPERIMENTAL

Camrelizumab, gemcitabin, cisplatin

Intervention Type: 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.

Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy

Intervention Type: 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.

Interventions

Camrelizumab, gemcitabin, cisplatin

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.

Intervention Type: DRUG

Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy

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.

Intervention Type: RADIATION

Other Intervention Names

PD-1 inhibitor; SBRT; IMRT

Eligibility Criteria

Inclusion Criteria

1. Male or female; 18-70 years of age.

2. Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).

3. Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial.

4. 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).

5. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.

6. ECOG performance status of 0 or 1.

7. Maximum diameter of brain metastatic lesion no more than 3cm.

8. 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.

9. Life expectancy more than 6 months.

Exclusion Criteria

1. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.

2. chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.

3. Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.

4. Patient with brain metastasis who needs decompression surgery.

5. Other malignancy or malignant hydrothorax.

6. Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.

7. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.

8. Use of large dose corticosteroids within 4 weeks before study drug administration.

9. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.

10. Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening

11. 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.

12. 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.

13. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.

14. Pregnancy or lactation.

15. Other ineligible patients according to attending doctor.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

professor & chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming-Yuan Chen, MD, PhD

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming-Yuan Chen, MD, PhD

Role: CONTACT

chmingy@mail.sysu.edu.cn

86-20-8734-3361

Rui You, MD, PhD

Role: CONTACT

yourui@sysucc.org.cn

86-13580439820

Facility Contacts

Ming-Yuan Chen, MD,PhD

Role: primary

chmingy@mail.sysu.edu.cn

86-20-8734-2422

Other Identifiers

SYSUCC-SBRT2022

Identifier Type: -

Identifier Source: org_study_id