Adebrelimab Combined with Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 2, Multicenter, Single-arm Clinical Trial
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients with histologically confirmed nasopharyngeal carcinoma.
• Tumor staged as IVA+T3N2M0 (AJCC 8th).
• Eastern Cooperative Oncology Group performance status ≤1.
• Patients must be informed of the investigational nature of this study and give written informed consent.
• 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
Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Contact Information
Primary
Jun Ma, M.D.
majun2@mail.sysu.edu.cn
+862087343469
Backup
Lei Chen, M.D.
chenlei@mail.sysu.edu.cn
Time Frame
Start Date:2024-07-23
Estimated Completion Date:2028-05-01
Participants
Target number of participants:50
Treatments
Experimental: Adebrelimab arm
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Adebrelimab 1200mg 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.