Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
NCT ID: NCT05340491
Last Updated: 2022-08-31
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
212 participants
INTERVENTIONAL
2022-04-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoradiotherapy+anti-PD-1
Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Toripalimab
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
Chemotherapy
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Intensity modulated radiotherapy
total 60-66Gy, 1.8-2.0Gy/f/day
Chemoradiotherapy
Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT.
Chemotherapy
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Intensity modulated radiotherapy
total 60-66Gy, 1.8-2.0Gy/f/day
Interventions
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Toripalimab
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
Chemotherapy
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Intensity modulated radiotherapy
total 60-66Gy, 1.8-2.0Gy/f/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not suitable for surgery;
* Histologic diagnosis of NPC (WHO II/III);
* TNM stage rII-IVa (AJCC/UICC 8th);
* ECOG 0-1 point;
* No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy or chemoradiotherapy;
* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Take effective contraceptions during and two months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria
* Have recurrence with local necrosis;
* Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
* Unexplained fever \> 38.5, except for tumor fever;
* Treated with ≥ 5 days antibiotics one month before enrollment;
* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
* Have known allergy to large molecule protein products or any compound of study therapy;
* Pregnant or breastfeeding;
* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
* Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Zhao Chong
Prof.
Principal Investigators
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Chong Zhao, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Peking University Third Hospital
Beijing, , China
Sichuan Cancer Hospital
Chengdu, , China
Fujian Province Cancer Hospital
Fuzhou, , China
Guizhou Cancer Hospital
Guiyang, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Jiangxi Cancer Hospital
Nanchang, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Zhongnan Hospital of Wuhan University
Wuhan, , China
Xijing Hospital
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Countries
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Central Contacts
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Facility Contacts
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Jingjing Miao, PhD
Role: primary
Suqing Tian
Role: primary
Shun Lu
Role: primary
Shaojun Lin
Role: primary
Feng Jin
Role: primary
Xiaozhong Chen
Role: primary
Jingao Li
Role: primary
Rengshen Wang
Role: primary
Chaosu Hu
Role: primary
Conghua Xie
Role: primary
Mei Shi
Role: primary
Qin Lin
Role: primary
Related Links
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Home Page of Sun Yat-sen University Cancer Center
Other Identifiers
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B2022-111-01
Identifier Type: -
Identifier Source: org_study_id