QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1/ CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma:A Randomized, Controlled, Multicenter Phase III Clinical Study.

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age ≥18 and ≤65 years

• Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.

• Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)

‣ Stage II: T1-3N2

⁃ Stage III: T1-4N3, T4N1-2

• Eastern Cooperative Oncology Group performance score of 0-11.

• Adequate marrow function: white blood cell count \> 4 × 10⁹/Lhemoglobin \>90g/L and platelet count \>100×10⁹/L

• Adequate hepatic and renal function:

‣ Total bilirubin ≤ 1.5 × upper limit of normal (ULN)

⁃ Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN

⁃ Alkaline phosphatase ≤ 2.5 × ULN

⁃ clearance rate ≥ 60 ml/min

• Other laboratory and clinical criteria

‣ Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)

⁃ For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required

⁃ For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits

• Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.

• Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).

Locations
Other Locations
China
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
Dongguan People's Hospital
NOT_YET_RECRUITING
Dongguan
First People's Hospital of Foshan
NOT_YET_RECRUITING
Foshan
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Fujian
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Guangzhou Panyu Central Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Cancer Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Jiangsu Cancer Hospital
NOT_YET_RECRUITING
Nanjing
Cancer Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
The Eye and ENT Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Hubei Province Cancer Hosiptal
NOT_YET_RECRUITING
Wuhan
Renmin Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Zhongshan People's Hospital
NOT_YET_RECRUITING
Zhongshan
Contact Information
Primary
Jun Ma, M.D.
majun2@mail.sysu.edu.cn
+862087343469
Backup
Rui Guo, M.D.
guorui@sysucc.org.cn
Time Frame
Start Date: 2025-05-04
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 580
Treatments
Experimental: QL1706 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. QL1706 5mg/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.
Active_comparator: Chemoradiation 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.
Related Therapeutic Areas
Sponsors
Collaborators: Qilu Pharmaceutical Co., Ltd.
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials