Nedaplatin: Nedaplatin is a second-generation platinum-like derivative, which is a cell cycle non-specific drug, with a mechanism of action and efficacy similar to cisplatin, and a wide anti-cancer spectrum
Cisplatin: Cisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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 \<ULN, endogenous creatinine clearance (Ccr) ≥ 55 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
Primary outcome measure(s)
NCI CTCAE 5.0 — 1 year Acute virulence side response
RESIST1.1 — 1year Use to assess recent efficacy
Trial sites (1)
Facility
City
Region
Status
The Affiliated Cancer Hospital of Guizhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.