Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
NCT ID: NCT04453826
Last Updated: 2020-09-28
Study Results
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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RECRUITING
PHASE3
388 participants
INTERVENTIONAL
2020-09-01
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Camrelizumab plus chemo-radiotherapy arm
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy with concurrent and adjuvant camrelizumab therapy.
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. 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 weeks.
4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy
Chemo-radiotherapy arm
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy.
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 weeks.
3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy
Interventions
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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. 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 weeks.
4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy
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 weeks.
3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
Yuebei People's Hospital
OTHER
Wuzhou Red Cross Hospital
OTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
Professor, Chief Doctor
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Su-Ming Pan, MD
Role: primary
Zhi-Gang Liu, MD, PhD
Role: primary
Jin-Hui Liang, MD
Role: primary
Other Identifiers
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SYSUCC-MYC-2020-1103
Identifier Type: -
Identifier Source: org_study_id
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