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

Launched by SUN YAT-SEN UNIVERSITY · Apr 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the combination of a PD-1 antibody and chemoradiotherapy to see if it is more effective than chemoradiotherapy alone for patients with recurrent nasopharyngeal carcinoma. This type of cancer affects the area behind the nose and can come back after treatment. The trial is currently recruiting patients aged 18 and older who have experienced a local recurrence of their cancer and are not candidates for surgery. Participants should not have received treatment for their recurrent cancer before, and they must meet certain health criteria to ensure their safety during the study.

If you choose to participate, you will be randomly assigned to receive either the new treatment (PD-1 antibody along with chemoradiotherapy) or the standard treatment (chemoradiotherapy alone). Throughout the study, your health will be monitored closely to check for any side effects and to see how well the treatment is working. It's important to know that you will need to provide informed consent, meaning you'll be fully informed about the trial and its risks before participating. This trial aims to find better treatment options for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.