Overview

Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma

Status:
Not yet recruiting

Trial end date:
2026-09-01

Target enrollment:
0

Participant gender:
All

Summary

This study was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for the selection of clinical treatment options.

Phase:

Phase 2

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Guiyang Medical University

Treatments:

Nedaplatin

Criteria

Inclusion Criteria:

1. voluntarily participated and signed the informed consent form in writing

2. is 18-70 and gender unlimited

3. histologically proved to be squamous cell carcinoma

4. as AJCC(version 8): -A, ⅣB head and neck squamous carcinoma unable or denied surgery;
~ A, ⅣB squamous carcinoma of the head and neck with the following postoperative risk
factors: positive or proximal resection, lymph node envelope invasion, nerve and
vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions.

5. card score ≥ 70

6. survival is expected to be ≥ for 6 months

7. fertility women should guarantee contraception during entering the study

8. Hemoglobin (HGB) ≥ 100 g/L, leukocyte (WBC) ≥ 3.5 × 10^9 / L*(unit normal), Platelet
(PLT) ≥ 100 × 10^9 / L(unit normal), neutrophil (WBC) ≥ 1.5 × 10^9 / L*(unit normal)

9. liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT)
<; total bilirubin <1.5 × ULN

10. renal function: Serum creatinine ml/min

11. has no severe complications such as hypertension, diabetes, coronary heart disease,
and psychiatric history

12. (no history of head and neck radiotherapy or chemotherapy within 3 months)

Exclusion Criteria:

1. has a distant transfer

2. has received epidermal growth factor targeted or immunotherapy

3. has developed other malignant tumors (except for cured basal cell carcinoma or
cervical carcinoma in situ)

4. pregnant women or lactating women and women of childbearing age who refuse
contraception during the treatment observation period

5. has a serious history of severe allergies or abnormalities

6. refused or cannot sign an informed consent to participate in the trial

7. substance abuse or alcohol addicts