Clinical Trials /

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

NCT04453826

Description:

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.

Related Conditions:
  • Non-Keratinizing Sinonasal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: SYSUCC-MYC-2020-1103
  • NCT ID: NCT04453826

Conditions

  • Nasopharyngeal Carcinoma
  • Chemotherapy
  • Radiotherapy
  • PD-1 Therapy

Interventions

DrugSynonymsArms
Camrelizumab plus chemo-radiotherapyCamrelizumab plus chemo-radiotherapy arm
Chemo-radiotherapy aloneChemo-radiotherapy arm

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Camrelizumab plus chemo-radiotherapy armExperimental3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy with concurrent and adjuvant camrelizumab therapy.
  • Camrelizumab plus chemo-radiotherapy
Chemo-radiotherapy armActive Comparator3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy.
  • Chemo-radiotherapy alone

Eligibility 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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progress-free survival (PFS)
Time Frame:3 years
Safety Issue:
Description:Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:3 years
Safety Issue:
Description:Defined as the time interval from randomization to death due to any cause.
Measure:Distant Metastasis-Free Survival (DMFS)
Time Frame:3 years
Safety Issue:
Description:Defined as the time interval from randomisation to the date of first distant metastases.
Measure:Locoregional Relapse-Free Survival (LRRFS)
Time Frame:3 years
Safety Issue:
Description:Defined as the time from randomisation to the date of first locoregional relapse.
Measure:Incidence of treatment related acute complications
Time Frame:up to 1 years
Safety Issue:
Description:The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measure:Incidence of treatment related late complications
Time Frame:up to 3 years
Safety Issue:
Description:The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measure:Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time Frame:up to 3 years
Safety Issue:
Description:Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Measure:Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time Frame:up to 3 years
Safety Issue:
Description:Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sun Yat-sen University

Last Updated

June 27, 2020