Clinical trial · Interventional
Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
Prospective, Multicentric, Randomized Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the treatment group
- description
- Nedplatin combined with intensive radiotherapy group
- interventionNames
- Drug: Nedaplatin
- type
- ACTIVE_COMPARATOR
- label
- the control group
- description
- Cisplatin was combined with the IMRT group
- interventionNames
- Drug: Cisplatin
Primary outcomes (2)
- measure
- NCI CTCAE 5.0
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available