Induction Chemoimmunotherapy Followed by Concurrent Radiotherapy and Nimotuzumab in Elderly Patients (>60 Years) with Locally Advanced Nasopharyngeal Carcinoma: A Single-Arm, Phase II Clinical Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600121720

Enrollment

Unknown

Registered

2026-04-02

Start date

2026-04-06

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Experimental group:1.Induction chemotherapy combined with immunotherapy:Sintilimab 200 mg intravenous infusion (ivgtt) on day 0, plus Gemcitabine 1000 mg/m^2 intravenous infusion (ivgtt) on days 1 and

95% PGTVnd: 69.96 Gy / 2.12 Gy per fraction / 33 fractions

95% PGTVrpn: 69.96 Gy / 2.12 Gy per fraction / 33 fractions

95% PTV1: 60.06 Gy / 1.82 Gy per fraction / 33 fractions

95% PTV2: 50.4 Gy / 1.8 Gy per fraction / 28 fractions. (b) Nimotuzumab: 200 mg once weekly for a total of 6 doses. (3) Maintenance immunotherapy:Sintilimab 200 mg intravenous infusion (ivgtt) on day

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form; 2. Age > 60 years; 3. Pathologically confirmed newly diagnosed nasopharyngeal carcinoma (WHO pathological type II or III); 4.AJCC 8th edition stage T1-4N2-3/T4N1; 5. Karnofsky Performance Status (KPS) score >= 70; 6.No severe hematopoietic dysfunction, cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency; 7.Normal thyroid, adrenal, and pituitary function.

Exclusion criteria

Exclusion criteria: 1. Concurrent treatment with other systemic glucocorticoids/immunosuppressants; 2.Presence of active autoimmune disease, human immunodeficiency virus (HIV) infection, or active infection requiring systemic treatment; 3.Receipt of live vaccine within < 30 days; 4. History of or concurrent second primary malignancy (excluding non-melanoma skin cancer, thyroid cancer, cervical carcinoma in situ, and contralateral non-invasive breast cancer); 5. Severe comorbidities (e.g., end-stage disease).

Design outcomes

Primary

Measure	Time frame
3-year Event Free Survival ;	—

Secondary

Measure	Time frame
Overall Survival;Event Free Survival ;Local Recurrence-Free Survival;Distant Metastasis-Free Survival;Clinical Complete Response Rate;Partial Response Rate;Objective Response Rate;Compliance;Quality of Life;Safety;	—

Countries

China

Contacts

Public ContactJia Chen

The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture

1010836606@qq.com+86 152 7438 8471

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026