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Recruiting NCT04453826

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

Phase III Interventional Nasopharyngeal Cancer Chemotherapy Radiotherapy PD-1 Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab plus chemo-radiotherapy, Chemo-radiotherapy alone.
Who it may be relevant to
Registry conditions: Nasopharyngeal Cancer, Chemotherapy, Radiotherapy, PD-1 Therapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.
  • 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 week

Primary outcome measures

  • Progress-free survival (PFS) [Time frame: 3 years]
Secondary outcome measures (7)
  • Overall Survival (OS) [Time frame: 3 years]
  • Distant Metastasis-Free Survival (DMFS) [Time frame: 3 years]
  • Locoregional Relapse-Free Survival (LRRFS) [Time frame: 3 years]
  • Incidence of treatment related acute complications [Time frame: up to 1 years]
  • Incidence of treatment related late complications [Time frame: up to 3 years]
  • Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [Time frame: up to 3 years]
  • 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]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
  • Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).
  • 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.
  • Aged between 18-70 years.
  • Karnofsky scale (KPS)≥70.
  • Normal bone marrow function.
  • Normal liver and kidney function:
  • total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
  • creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
  • Given written informed consent.

Exclusion criteria

  • Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
  • Recurrent or metastatic nasopharyngeal carcinoma.
  • 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.
  • Has known allergy to large molecule protein products or any compound of study therapy.
  • Has known subjects with other malignant tumors.
  • Has any active autoimmune disease or history of autoimmune disease.
  • Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
  • The laboratory examination value does not meet the relevant standards within 7 days before enrollment
  • Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
  • Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
  • 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.
  • Has a known history of human immunodeficiency virus (HIV).
  • Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
  • Has received a live vaccine within 4 weeks of planned start of study therapy.
  • Pregnancy or breast feeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Cancer Center of Guangzhou Medical University — Guangzhou
  • Yuebei People's Hospital — Shaoguan
  • Zhongshan People's Hospital — Zhongshan
  • The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
  • Wuzhou Red Cross Hospital — Wuzhou

Publications

  • You R, Xu GQ, Ding X, Liang JH, Liu ZG, Zou X, Liu YP, Hu GY, Liu YM, Duan CY, Liu LZ, Zhang WJ, Liu Q, Li HF, Ouyang YF, Duan XT, Wang Q, Peng L, Liang JL, Feng ZK, Qin ZH, Liu X, He ZK, Zhang B, Long GX, Jiang YH, Lei F, Huang PY, Hua YJ, Chen MY. Standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, ope PMID 41667193

Identifiers

NCT: NCT04453826 · SYSUCC-MYC-2020-1103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗