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.
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 Cancer
- Chemotherapy
- Radiotherapy
- PD-1 Therapy
Interventions
Drug | Synonyms | Arms |
---|
Camrelizumab plus chemo-radiotherapy | | Camrelizumab plus chemo-radiotherapy arm |
Chemo-radiotherapy alone | | Chemo-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
Name | Type | Description | Interventions |
---|
Camrelizumab plus chemo-radiotherapy arm | Experimental | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy with concurrent and adjuvant camrelizumab therapy. | - Camrelizumab plus chemo-radiotherapy
|
Chemo-radiotherapy arm | Active Comparator | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy. | |
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: | Recruiting |
Lead Sponsor: | Sun Yat-sen University |
Last Updated
September 28, 2020