Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2030-02-20

Brief Summary

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This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.

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Detailed Description

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The goals of this clinical trial includes: ① To confirm whether LRRFS after reduced-dose radiotherapy in combination with chemotherapy and immunotherapy is non-inferior to LRRFS after conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response; ② To explore the impact of reduced-dose radiotherapy on 3-year OS, 3-year PFS, 3-year DMFS, 3-year LRFS and 3-year RRFS for treatment-sensitive stage III NPC patients screened out according to the treatment response; ③ To explore the impact of reduced-dose radiotherapy on radiotherapy complications and quality of life; ④ To explore the interaction between different clinical factors and the impact of reduced-dose radiotherapy on the prognosis of patients; ⑤ To explore the biomarkers of sensitivity to chemotherapy and radiotherapy for patients with nasopharyngeal carcinoma and the underlying mechanism.

For these purposes, we plan to prospectively enroll stage III NPC patients from 9 hospitals in China. The participants will receive 3 cycles of induction chemotherapy (GP regimen + Camrelizumab) followed by intensity-modulated radiation therapy. 2 cycles of concurrent chemotherapy will be administered during the radiotherapy. Patients' treatment response will be evaluated with MRI examination after 27 fractions of radiotherapy. If the treatment response after 27 fractions of radiotherapy is complete remission, the participants will be randomized into reduced-dose radiotherapy group and conventional-dose radiotherapy group. If the treatment response after 27 fractions of radiotherapy is not complete remission, the participants will be assigned to the unenrolled group. All the participants in the unenrolled group will receive conventional-dose radiotherapy. After the radiotherapy, all the participants will receive 9 cycles of Camrelizumab immunotherapy. Besides, all the participants in the unenrolled group will also receive metronomic adjuvant capecitabine chemotherapy for 1 year. The prognosis, complication, and quality of life will be compared between the reduced-dose radiotherapy group and the conventional-dose radiotherapy group.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced-dose radiotherapy group

All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by reduced-dose intensity-modulated radiation therapy (IMRT; 6360cGy, 30 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles.

Group Type EXPERIMENTAL

PD-1 blocking antibody

Intervention Type DRUG

1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

Gemcitabine

Intervention Type DRUG

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

Cisplatin (80 mg/m2)

Intervention Type DRUG

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

Reduced-dose Intensity-modulated radiotherapy

Intervention Type RADIATION

1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day
2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.

Cisplatin (100 mg/m2)

Intervention Type DRUG

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

Conventional-dose radiotherapy group

All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles.

Group Type ACTIVE_COMPARATOR

PD-1 blocking antibody

Intervention Type DRUG

1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

Gemcitabine

Intervention Type DRUG

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

Cisplatin (80 mg/m2)

Intervention Type DRUG

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

Conventional-dose Intensity-modulated radiotherapy

Intervention Type RADIATION

1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day
2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

Cisplatin (100 mg/m2)

Intervention Type DRUG

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

Not-enrolled population

All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles. Besides, all the participants should also receive metronomic adjuvant capecitabine chemotherapy (capecitabine 650 mg/m2 p.o. BID 1 year) immediately after the completion of concurrent chemoradiotherapy.

Group Type OTHER

PD-1 blocking antibody

Intervention Type DRUG

1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

Gemcitabine

Intervention Type DRUG

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

Cisplatin (80 mg/m2)

Intervention Type DRUG

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

Conventional-dose Intensity-modulated radiotherapy

Intervention Type RADIATION

1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day
2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

Cisplatin (100 mg/m2)

Intervention Type DRUG

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

Capecitabine

Intervention Type DRUG

Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

Interventions

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PD-1 blocking antibody

1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

Intervention Type DRUG

Gemcitabine

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

Intervention Type DRUG

Cisplatin (80 mg/m2)

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

Intervention Type DRUG

Reduced-dose Intensity-modulated radiotherapy

1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day
2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.

Intervention Type RADIATION

Conventional-dose Intensity-modulated radiotherapy

1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day
2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

Intervention Type RADIATION

Cisplatin (100 mg/m2)

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

Intervention Type DRUG

Capecitabine

Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

Intervention Type DRUG

Other Intervention Names

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Camrelizumab GEM DDP Reduced-dose IMRT Conventional-dose IMRT DDP

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 Years to 65 Years;
2. Eastern Cooperative Oncology Group performance status ≤1;
3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma;
4. Tumor staged as Stage III (AJCC 8th);
5. Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion);
6. Normal bone marrow function: white blood cell count \> 4×10\^9/L, hemoglobin \> 90g/L, platelet count \> 100×10\^9/L;
7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate transaminase ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN, creatinine clearance rate ≥ 60 ml/min;
8. Receive 3 cycles of indction chemotherapy (GP regimen + Camrelizumab);
9. Plasma EBV DNA after the second cycle of concurrent chemotherapy: 0;
10. Complete remission after 27 fractions of radiotherapy based on the MRI examination of the nasopharynx and neck (According to Response Evaluation Criteria in Solid Tumors 1.1);
11. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
12. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.

Exclusion Criteria

1. Hepatitis B virus surface antigen (HBsAg) positive and Hepatitis B virus DNA \> 1000 copies/ml;
2. Anti-hepatitis C virus positive;
3. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
4. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved;
5. Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
6. Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
7. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible;
8. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
9. Active infection requiring systemic treatment;
10. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
11. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma;
12. Receive treatment for the local or regional disease other than that specified in the research plan;
13. Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
14. Allergy to macromolecular protein preparations, or any component of Camrelizumab;
15. Receiving live vaccine within 30 days of the initial Camrelizumab;
16. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast;
17. History of psychotropic disease, alcoholism or drug abuse, and other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jun Ma, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Ma

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING