RecruitingPhase 3NCT03907826

PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

212 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria12

  • Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
  • Not suitable for surgery;
  • Newly histologic diagnosis of NPC (WHO II/III);
  • Clinical stage rII-IVa (AJCC/UICC 8th);
  • ECOG 0-1 point;
  • No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
  • No contraindications to immunotherapy or radiotherapy;
  • 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 Criteria12

  • Treated with anti-tumor Chinese medicine treatment;
  • 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 ≥10E4copiers/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.

Interventions

DRUGPD-1 blocking antibody

Toripalimab 240mg, D1, every 3 weeks per cycle

DRUGGP

Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

RADIATIONIMRT

IMRT 60-66Gy, 1.8-2.0Gy/f/day


Locations(12)

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

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NCT03907826


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