Trial Title:
Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma
NCT ID:
NCT05587374
Condition:
Nasopharyngeal Carcinoma
Nasopharyngeal Cancer
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Gemcitabine
Antibodies, Bispecific
Conditions: Keywords:
immunotherapy
PD-1/CTLA-4 Bi-specific Antibody
Chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy
and for 14 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy
and adjuvant chemotherapy, respectively.
Arm group label:
Cadonilimab arm
Other name:
PD-1/CTLA-4 bi-specific antibody
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Arm group label:
Cadonilimab arm
Arm group label:
Chemoradiation arm
Other name:
GEM
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent
cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Arm group label:
Cadonilimab arm
Arm group label:
Chemoradiation arm
Other name:
DDP
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiotherapy
Description:
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33
fractions.
Arm group label:
Cadonilimab arm
Arm group label:
Chemoradiation arm
Other name:
IMRT
Summary:
The trial aimed to compare cadonilimab combined with induction chemotherapy plus
concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in high-risk
locoregionally-advanced nasopharyngeal carcinoma (LANPC).
Detailed description:
The trial plans to enroll patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0)
locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in
a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin
and concurrent cisplatin-radiation or the same regimen plus cadonilimab in induction
chemotherapy and adjuvant chemotherapy. All patients will receive intensity-modulated
radiotherapy (IMRT). Cadonilimab will begin on day 1 of induction chemotherapy and
continue every 3 weeks for 3 cycles in induction therapy and for 14 cycles in adjuvant
therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with histologically confirmed nasopharyngeal carcinoma.
2. Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
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 cadonilimab.
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:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Jiang
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China
Address:
City:
Hefei
Zip:
230041
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Gao
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun-Lin Yi
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Chuan-Ben Chen
Contact backup:
Last name:
Su-Fang Qiu
Facility:
Name:
Dongguan Peaple's Hospital
Address:
City:
Dongguan
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Gang Liu
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi-Min Liu
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Ma
Phone:
+862087343469
Email:
majun2@mail.sysu.edu.cn
Facility:
Name:
Shenzhen People's Hospital
Address:
City:
Shenzhen
Zip:
518001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xian-Ming Li
Facility:
Name:
Zhongshan city Peaple's Hospital
Address:
City:
Zhongshan
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Lei
Facility:
Name:
Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiao-Dong Zhu, MD
Facility:
Name:
Cancer Hospital of Guizhou Medical University
Address:
City:
Guiyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Jin, MD
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang-Pan Li
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Ya-Hua Zhong
Facility:
Name:
Hubei Province Cancer Hosiptal
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
De-Sheng Hu, M.D.
Facility:
Name:
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Guang-Yuan Hu
Facility:
Name:
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kun-Yu Yang, MD
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ya-Qian Han
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang-Fang Shen, MD
Facility:
Name:
Changhai Hospital of Shanghai
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Huo-Jun Zhang, M.D.
Start date:
August 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Akeso Pharmaceuticals, Inc.
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/NCT05587374
