Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05092217
• Other study ID #: rNPC-2021-Dehui Wang
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 20, 2021
• Est. completion date: October 20, 2024

Study information

• Verified date: October 2021
• Source: Eye & ENT Hospital of Fudan University
• Contact: Wanpeng Li, MD
• Phone: 13262856870
• Email: 18879117831[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed recurrent nasopharyngeal carcinoma

2. The recurrence time is more than 6 months from the end of radiotherapy.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

4. According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team.

5. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.

6. Given written informed consent.

Exclusion Criteria:

1. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.

2. Has known subjects with other malignant tumors.

3. Has participated in other drug trials within 3 months of planned start of study treatment.

4. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.

5. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.

6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.

7. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.

8. 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.

9. Has received a live vaccine within 4 weeks of planned start of study treatment.

10. Pregnancy or breast feeding.

11. Cannot complete regular follow-up.

12. Local recurrence of nasopharyngeal carcinoma with distant metastasis

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Tirelizumab
Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

Procedure:
• salvage surgery
Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival(PFS)	Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause	2 years
Secondary	Overall survival(OS)	Defined as the time interval from randomization to death due to any cause.	2 years
Secondary	Locoregional failure-free survival(LRRFS)	The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit	2 years
Secondary	Distant metastasis-free survival(DMFS)	The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.	2 years
Secondary	Incidence of treatment related complications	Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up	2 years