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Trial Title:
Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma
NCT ID:
NCT06349889
Condition:
Nasopharyngeal Carcinoma
Nasopharyngeal Cancer
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Conditions: Keywords:
immunotherapy
Chemoradiotherapy
PD-L1
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Drug: Adebrelimab Adebrelimab 20mg/kg will be given every 3 weeks for 3 cycles in
induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of
induction chemotherapy and adjuvant chemotherapy, respectively.
Other Names:
PD-L1 antibody
Drug: Gemcitabine Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles
before radiation.
Other Names:
GEM
Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation;
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Other Names:
DDP
Radiation: Intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy
(IMRT) of 6996cGy will be given in 33 fractions.
Other Names:
IMRT
Arm group label:
Adebrelimab arm
Summary:
This trial aims to study the role of Adebrelimab combined with induction chemotherapy
plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced
nasopharyngeal carcinoma(LANPC).
Detailed description:
The trial plans to enroll patients with stage IVA+T3N2M0 (AJCC 8th)
locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients receive 3 cycles of
induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation
plus Adebrelimab in induction chemotherapy and adjuvant chemotherapy. Adebrelimab will
begin on day 1 of induction chemotherapy and continue every 3 weeks for 3 cycles in
induction therapy and for 9 cycles in adjuvant therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with histologically confirmed nasopharyngeal carcinoma.
2. Tumor staged as IVA+T3N2M0 (AJCC 8th).
3. Eastern Cooperative Oncology Group performance status ≤1.
4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and
platelet count ≥100×10e9/L.
5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of
normal (ULN), and bilirubin ≤ 1.5×ULN.
6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault
formula).
7. Patients must be informed of the investigational nature of this study and give
written informed consent.
8. Women of childbearing potential (WOCBP) who are sexually active must be willing to
adhere to effective contraception during treatment and for 1 year after the last
dose of study drug. Men who are sexually active with WOCBP must be willing to adhere
to effective contraception during treatment and for 1 year after the last dose of
the study drug
Exclusion Criteria:
1. Age > 65 or < 18.
2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3
copies/ml or 200IU/ml
3. Hepatitis C virus (HCV) antibody positive
4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with
replacement therapy, and skin disease that doesn't require systemic treatment (e.g.,
vitiligo, psoriasis, or alopecia).
5. Has any condition that required systemic corticosteroid (equivalent to prednisone
>10mg/d) or other immunosuppressive therapy within 28 days before informed consent.
Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale
or topical corticosteroid will be allowed.
6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients
with adequately treated active TB over 1 year ago will be allowed.
7. Has a known history of interstitial lung disease.
8. Has received a live vaccine within 30 days before informed consent or will receive a
live vaccine in the near future.
9. Is pregnant or breastfeeding.
10. Prior malignancy within 5 years, except in situ cancer, adequately treated
non-melanoma skin cancer, and papillary thyroid carcinoma.
11. Has known allergy to large molecule protein products or any compound of Adebrelimab.
12. Has a known history of human immunodeficiency virus (HIV) infection.
13. Any other condition, including symptomatic heart failure, unstable angina,
myocardial infarction, active infection requiring systemic therapy, 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Jian Guan, M.D.
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Lei Liu, M.D.
Start date:
May 1, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349889
