Immunotherapy and Chemotherapy in Unresectable Recurrent Loco-regionally Advanced Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single center, phase II trial to evaluate the safety and efficacy of postponing or omitting re-irradiation after first-line systemic therapy with tislelizumab and chemotherapy in patients with unresectable recurrent loco-regionally advanced nasopharyngeal carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

Inclusion Criteria:

1. Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;

2. Not suitable for surgery;

3. Clinical stage rT3-4N0-2 (rII-IVa, AJCC/UICC 8th);

4. ECOG score 0-1;

5. No prior treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;

6. No contraindications to immunotherapy or chemoradiotherapy;

7. Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;

8. Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;

9. Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);

10. Take effective contraceptions during and two months after treatment;

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

Exclusion Criteria:

1. Have local necrosis in recurrent lesions, estimated with bleeding risk;

2. Unexplained fever > 38.5 ℃, except for tumor fever;

3. Treated with ≥ 5 days antibiotics one month before enrollment;

4. Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);

5. Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;

6. Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;

7. Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;

8. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;

9. Have known allergy to large molecule protein products or any compound of study therapy;

10. Pregnant or breastfeeding;

11. Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;

12. Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.