Nasopharyngeal Carcinoma Clinical Trials

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GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to explore the efficacy and safety of neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients.

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

• Patients must be informed of the investigational nature of this study and give written informed consent.

• Age ≥ 18 years and ≤65 years, men or non-pregnant women.

• Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).

• Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th).

• No previous anti-tumor treatment.

• Eastern Cooperative Oncology Group (ECOG) score 0 or 1.

• Adequate marrow function: White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.

• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) ≤2×upper limit of normal (ULN).

• Adequate renal function: creatinine clearance rate ≥ 60 ml/min or Creatinine ≤ 1.5× upper limit of normal value.

Locations
Other Locations
China
Foshan First People's Hospital
NOT_YET_RECRUITING
Foshan
Affiliated cancer hospital and institute of guangzhou medical university
NOT_YET_RECRUITING
Guangzhou
Sun Yat-Sen Memorial Hospital
NOT_YET_RECRUITING
Guangzhou
The affiliated panyu central hospital of guangzhou medical university
NOT_YET_RECRUITING
Guangzhou
ZhuJiang Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Liuzhou Workers Hospital
NOT_YET_RECRUITING
Liuzhou
Guangxi Medical University Affiliated Cancer Hospital
NOT_YET_RECRUITING
Nanning
Cancer hospital of Shantou university medical college
NOT_YET_RECRUITING
Shantou
Cancer hospital Chinese academy of medical sciences, Shenzhen center
NOT_YET_RECRUITING
Shenzhen
The second people's hospital of Shenzhen
RECRUITING
Shenzhen
The university of Hongkong - Shenzhen hospital
NOT_YET_RECRUITING
Shenzhen
Guangdong Medical School First Affiliated Hospital
NOT_YET_RECRUITING
Zhangjiang
Contact Information
Primary
Hai-Qiang Mai, MD, PhD
maihq@sysucc.org.cn
8613570027338
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2028-06-18
Participants
Target number of participants: 216
Treatments
Experimental: GP combined with adebrelimab neoadjuvant therapy+CCRT
Adebrelimab (1200mg) to be administered on Day 1 of the Lead-in Phase (-14 days to the start of the neoadjuvant chemoimmunotherapy phase). Patients receive neoadjuvant therapy with gemcitabine (1000mg per square meter on day 1,8) , cisplatin (80mg per square meter on day 1) and adebrelimab (given 1200mg on day 1) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg per square meter) concurrent every three weeks during radiotherapy (D1, D22, D43 of RT).
Active_comparator: GP neoadjuvant therapy+CCRT
Patients receive neoadjuvant therapy with gemcitabine (1000mg per square meter on day 1,8) , cisplatin (80mg per square meter on day 1) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg per square meter) concurrent every three weeks during radiotherapy (D1, D22, D43 of RT).
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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