Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT04453826

PHASE3

Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.

Official title: A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

388

Start Date

2020-09-01

Completion Date

2028-09

Last Updated

2020-09-28

Healthy Volunteers

Conditions

Nasopharyngeal Cancer Chemotherapy Radiotherapy PD-1 Therapy

Interventions

DRUG

Camrelizumab plus chemo-radiotherapy

1. Camrelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of camrelizumab are concurrently used during radiotherapy and camrelizumab are maintained for 1 year after the end of radiotherapy. 2. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 3. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy

DRUG

Chemo-radiotherapy alone

1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy

Inclusion Criteria: 1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). 2. Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition). 3. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL after 3 cycles of GP induction chemotherapy. 4. Aged between 18-70 years. 5. Karnofsky scale (KPS)≥70. 6. Normal bone marrow function. 7. Normal liver and kidney function: 1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit; 2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit. 8. Given written informed consent. Exclusion Criteria: 1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma. 2. Recurrent or metastatic nasopharyngeal carcinoma. 3. Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy. 4. Has known allergy to large molecule protein products or any compound of study therapy. 5. Has known subjects with other malignant tumors. 6. Has any active autoimmune disease or history of autoimmune disease. 7. Has a history of psychiatric substance abuse, alcoholism, or drug addiction. 8. The laboratory examination value does not meet the relevant standards within 7 days before enrollment 9. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication. 10. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year. 11. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent. 12. 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. 13. Has a known history of human immunodeficiency virus (HIV). 14. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive. 15. Has received a live vaccine within 4 weeks of planned start of study therapy. 16. Pregnancy or breast feeding.

Locations (6)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China