Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557020
• Other study ID #: NPC2020-001
• Status: Recruiting
• Phase: Phase 3
• Start date: December 30, 2020
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Jiangxi Provincial Cancer Hospital
• Contact: Jingao Li
• Phone: 86-791-88300252
• Email: lijingao[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma

2. Clinical staged as T4 or N3 (according to the 8th AJCC edition)

3. No evidence of distant metastasis (M0)

4. Male and no pregnant female

5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1

6. WBC = 4×109 /L and PLT =4×109 /L and HGB =90 g/L

7. Normal liver function test (ALT?AST = 2.5×ULN, TBIL= 2.0×ULN)

8. Normal renal function test ( creatinine clearance =60 ml/min)

Exclusion Criteria:

1. Recurrent or distant metastatic disease.

2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.

3. History of radiotherapy or chemotherapy.

4. History of immunodeficiency disease

5. History of organ transplantation

6. Presence of life-threatening illness

7. Uncontrolled hypercalcemia

8. Severe uncontrolled medical conditions or active infectious diseases

9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.

10. Pregnant or breastfeeding female

11. Emotional disturbance or mental illness

12. Refusal or inability to sign informed consent

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• PD-1 antibody
neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
• Gemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
• Cisplatin
neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT

Radiation:
• IMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Ganzhou Cancer Hospital	Ganzhou	Jiangxi
China	First Affiliated hospital of Gannan Medical University	Guangzhou	Jiangxi
China	Jiujiang University Affiliated Hospital	Jiujiang	Jiangxi
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	Pingxiang Peoples' Hospital	Pingxiang	Jiangxi
China	Suizhou Central Hospital	Suizhou	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival (PFS)	From date of randomization to date of first documentation of progression or death due to any cause.	3 year
Secondary	Overall Survival (OS)	From date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.	3 year
Secondary	Distant Metastasis-Free Survival (DMFS)	From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.	3 year
Secondary	Locoregional Relapse-Free Survival (LRRFS)	From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit.	3 year
Secondary	Objective Response Rate (ORR)	Either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).	within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
Secondary	adverse events (AEs)	Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0	3 year