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NCT04453826 | RECRUITING | Nasopharyngeal Cancer

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

Sun Yat-sen University

Information provided by (Responsible Party):

Ming-yuan Chen

Brief 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.

Condition or disease

Nasopharyngeal Cancer

Chemotherapy

Radiotherapy

PD-1 Therapy

Intervention/treatment

Camrelizumab plus chemo-radiotherapy

Chemo-radiotherapy alone

Phase

PHASE3

Detailed Description:

Through multicenter, open-label, randomised clinical trials, high risk patients with nasopharyngeal carcinoma (staged as II-III with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL after 3 cycles of GP induction chemotherapy and staged as IVa) are randomized into camrelizumab plus chemo-radiotherapy arm and chemo-radiotherapy arm. The efficacy and safety of patients between these two arms are compared.

Study Type : INTERVENTIONAL
Estimated Enrollment : 388 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2020-09-01
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2028-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

Location Details

NCT04453826

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How to Participate

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Locations

RECRUITING

China, Guangdong

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

NOT YET RECRUITING

China, Guangdong

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China, 510095

NOT YET RECRUITING

China, Guangdong

Yuebei People's Hospital

Hall S, Guangdong, China, 512025

RECRUITING

China, Guangdong

Zhongshan People's Hospital

Zhongshan, Guangdong, China, 528403

RECRUITING

China, Guangdong

The Fifth Affiliated Hospital of Sun Yat-sen University

Z tiger returns, Guangdong, China, 519000

NOT YET RECRUITING

China, Guangxi

Wuzhou Red Cross Hospital

w U axis, Guangxi, China, 543002