QL1706 (IPD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

Last updated: December 23, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Nasopharyngeal Cancer

Treatment

Gemcitabine

QL1706

Cisplatin

Clinical Study ID

NCT06749899
2024-FXY-409-FLK
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients with histologically confirmed nasopharyngeal carcinoma.

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

  3. Eastern Cooperative Oncology Group performance status ≤1.

  4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L andplatelet count ≥100×10e9/L.

  5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit ofnormal (ULN), and bilirubin ≤ 1.5×ULN.

  6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gaultformula).

  7. Patients must be informed of the investigational nature of this study and givewritten informed consent.

  8. Women of childbearing potential (WOCBP) who are sexually active must be willing toadhere to effective contraception during treatment and for 1 year after the lastdose of study drug. Men who are sexually active with WOCBP must be willing to adhereto effective contraception during treatment and for 1 year after the last dose ofthe study drug

Exclusion

Exclusion Criteria:

  1. Age > 65 or < 18.

  2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3copies/ml or 200IU/ml

  3. Hepatitis C virus (HCV) antibody positive

  4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated withreplacement therapy, and skin disease that doesn't require systemic treatment (e.g.,vitiligo, psoriasis, or alopecia).

  5. Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent.Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhaleor topical corticosteroid will be allowed.

  6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patientswith adequately treated active TB over 1 year ago will be allowed.

  7. Has a known history of interstitial lung disease.

  8. Has received a live vaccine within 30 days before informed consent or will receive alive vaccine in the near future.

  9. Is pregnant or breastfeeding.

  10. Prior malignancy within 5 years, except in situ cancer, adequately treatednon-melanoma skin cancer, and papillary thyroid carcinoma.

  11. Has known allergy to large molecule protein products or any compound of QL1706.

  12. Has a known history of human immunodeficiency virus (HIV) infection.

  13. Any other condition, including symptomatic heart failure, unstable angina,myocardial infarction, active infection requiring systemic therapy, mental illnessor domestic/social factors, deemed by the investigator to be likely to interferewith a patient's ability to sign informed consent, cooperate and participate in thestudy, or interferes with the interpretation of the results.

Study Design

Total Participants: 580
Treatment Group(s): 4
Primary Treatment: Gemcitabine
Phase: 3
Study Start date:
December 19, 2024
Estimated Completion Date:
December 01, 2030

Study Description

The trial plans to enroll patients with stage T4N1and T1-4N2-3 (AJCC 9th) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or the same regimen plus QL1706 in induction chemotherapy and adjuvant chemotherapy. All patients will receive intensity-modulated radiotherapy (IMRT). QL1706 will begin on day 1 of induction chemotherapy and continue every 3 weeks for 3 cycles in induction therapy and for 9 cycles in adjuvant therapy.

Connect with a study center

  • Fujian Cancer Hospital

    Fuzhou,, Fujian
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong
    China

    Site Not Available

  • First People's Hospital of Foshan

    FoShan, Guangdong
    China

    Site Not Available

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    GuangZhou, Guangdong 510060
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    GuangZhou, Guangdong 510060
    China

    Active - Recruiting

  • Guangzhou Panyu Central Hospital

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Zhongshan People's Hospital

    Zhongshan, Guangdong
    China

    Site Not Available

  • Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi 530000
    China

    Site Not Available

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Site Not Available

  • Hubei Province Cancer Hosiptal

    WuHan, Hubei 430000
    China

    Site Not Available

  • Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    WuHan, Hubei 430000
    China

    Site Not Available

  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Hunan Cancer Hospital

    ChangSha, Hunan 410000
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    ChangSha, Hunan
    China

    Site Not Available

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