An open-label, single-arm phase II clinical study of nimotuzumab concurrently with induction chemotherapy and sequential nimotuzumab combined with radiotherapy or concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma

Nimotuzumab concurrently with induction chemotherapy and combined with radiotherapy or concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000041139

Enrollment

Unknown

Registered

2020-12-19

Start date

2020-12-22

Completion date

Unknown

Last updated

2021-03-01

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

Conditions

Nasopharyngeal carcinoma

Interventions

Case series:Nimotuzumab plus induction chemotherapy,sequential nimotuzumab plus radiotherapy or nimotuzumab combined with concurrent chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. WHO type II / III nasopharynx cancer patients diagnosed by pathology; 2. Patients with stage III-IVA (UICC / AJCC 8th Edition, except T3-4N0); 3. Patients receiving intensity modulated radiation therapy; 4. Patients with ECoG PS 0-1; 5. Patients aged 18-70 years; 6. Hematological examination: WBC >= 4 x 10^9 / L, neutrophil >= 2 x 10^9 / L, hemoglobin >= 90g / L, platelet >= 100 x 10^9 / L; 7. Liver function: ALT, AST = 60 ml / min; 9. Patients with informed consent.

Exclusion criteria

Exclusion criteria: 1. Who pathological classification of patients with keratinized squamous cell carcinoma or basal cell carcinoma; 2. Palliative treatment; 3. Patients with previous history of other malignant tumors (skin basal cell carcinoma / squamous cell carcinoma, cervical carcinoma in situ excluded); 4. Pregnant or lactating women (women of childbearing age should consider pregnancy test and require effective contraception during treatment); 5. Patients with previous radiotherapy history (except for skin non melanoma outside the planned target area); 6. Patients who have received chemotherapy or surgery for primary tumor or lymph node (except for diagnostic surgery); 7. Any patients with serious concomitant diseases that may bring risks to the trial or affect the trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis, diabetes mellitus with poor blood glucose control (fasting blood glucose > 1.5 x ULN) and mood disorders requiring treatment.

Design outcomes

Primary

Measure	Time frame
Disease-free survival rate;	—

Secondary

Measure	Time frame
Overall survival rate;Distant metastasis-free survival rate;Locoregional relapse-free survival rate;Objective response rate;Toxicity of treatment;	—

Countries

China

Contacts

Public ContactJian-Wu Ding

The Second Affiliated Hospital of Nanchang University

dingjianwu2008@126.com+86 791-86107027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026