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

Who is this study for? Patients with recurrent nasopharyngeal carcinoma
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
Fujian Province Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Guizhou Cancer Hospital
RECRUITING
Guiyang
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Xijing Hospital
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Contact Information
Primary
Jingjing Miao
miaojingjing90@163.com
02087342638
Backup
Chong Zhao
zhaochong@sysucc.org.cn
02087342638
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 212
Treatments
Experimental: PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Active_comparator: Chemoradiotherapy
Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov