GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma

NCT06455410 | Recruiting Phase 2

• 1 other identifier: 2024-FXY-154
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate

  The proportion of patients who achieve complete response after neoadjuvant chemotherapy or chemoimmunotherapy as assessed by RECIST 1.1.

  11weeks

Secondary Outcomes (5)

• Event-free survival(EFS)

  2 years

• Overall survival (OS)

  2 years

• Locoregional relapse-free survival（LRRFS）

  2 years

• Distant metastasis-free survival (DMFS)

  2 years

• Toxicity profiles

  Up to 2 years

Study Arms (2)

GP combined with adebrelimab neoadjuvant therapy+CCRT

EXPERIMENTAL

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).

Drug: GP; Drug: Adebrelimab; Drug: concurrent chemoradiotherapy (CCRT)

GP neoadjuvant therapy+CCRT

ACTIVE COMPARATOR

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).

Drug: GP; Drug: concurrent chemoradiotherapy (CCRT)

Interventions

GP DRUG

gemcitabine + cisplatin

GP combined with adebrelimab neoadjuvant therapy+CCRT; GP neoadjuvant therapy+CCRT

Adebrelimab DRUG

a PD-L1 inhibitor

GP combined with adebrelimab neoadjuvant therapy+CCRT

concurrent chemoradiotherapy (CCRT) DRUG

concurrent chemoradiotherapy (CCRT)

GP combined with adebrelimab neoadjuvant therapy+CCRT; GP neoadjuvant therapy+CCRT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with recurrent or metastatic nasopharyngeal carcinoma.
• Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
• Prior therapy with radiation or systemic chemotherapy.
• Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
• Seropositivity for human immunodeficiency virus (HIV).
• Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
• Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti- PD-L1, anti-CTLA-4 antibodies.
• Patients with immunodeficiency disease or a history of organ transplantation.
• Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks.
• Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
• Patients with severe, uncontrolled disease or infections.
• Received other research drugs or in other clinical trials at the same time.
• Refuse or fail to sign the informed consent .
• Patients with other treatment contraindications.
• Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (12)

Foshan First People's Hospital

Foshan, Guangdong, China

NOT YET RECRUITING

Affiliated cancer hospital and institute of guangzhou medical university

Guangzhou, China

NOT YET RECRUITING

Sun Yat-Sen Memorial Hospital

Guangzhou, China

NOT YET RECRUITING

The affiliated panyu central hospital of guangzhou medical university

Guangzhou, China

NOT YET RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangzhou, China

NOT YET RECRUITING

Liuzhou Workers Hospital

Liuchow, China

NOT YET RECRUITING

Guangxi Medical University Affiliated Cancer Hospital

Nanning, China

NOT YET RECRUITING

Cancer hospital of Shantou university medical college

Shantou, China

NOT YET RECRUITING

Cancer hospital Chinese academy of medical sciences, Shenzhen center

Shenzhen, China

NOT YET RECRUITING

The second people's hospital of Shenzhen

Shenzhen, China

RECRUITING

The university of Hongkong - Shenzhen hospital

Shenzhen, China

NOT YET RECRUITING

Guangdong Medical School First Affiliated Hospital

Zhangjiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Hai-Qiang Mai, MD, PhD

CONTACT

8613570027338; maihq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2028
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (12)