Clinical trial · Interventional
A Trial of Endostar in Patients With Carcinoma of the Head and Neck
- 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)
The purpose of this study is to evaluate the efficacy and safety of recombinant human endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT.
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 |
|---|---|---|---|
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- SCCHN
- description
- patients with advanced squamous cell carcinoma of the head and neck.IMRT.
- interventionNames
- Drug: Endostar
- type
- EXPERIMENTAL
- label
- SCCHN-Endostar
- description
- patients with advanced squamous cell carcinoma of the head and neck.Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week(d-5-d-1, d3-d7, d10-d14, d17-d21)during IMRT.
- interventionNames
- Drug: Endostar
Primary outcomes (1)
- measure
- Progression-Free Survival (Mon); PFS, According to RECIST v1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unrespectable or postoperative recurrent squamous cell carcinoma of the head and neck; * No prior radiation or chemotherapy and biotherapy before; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy greater than 3 months; * Patients must have adequate bone marrow function: * Platelets ≥ 80×109/L * Hemoglobin ≥100 g/L * Absolute NeutrophilCount ≥1.5×109/L * white blood cell≥ 3.5×109/L * Patients must have adequate liver and renal function: * Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2.5 × upper limit of normal * Alkaline phosphatase \< 2.5 × upper limit of normal * Total bilirubin \< 1.5 mg/dL * Creatinine \<1.5 mg/dL× upper limit of normal * A cardiac ejection fraction \> 50%; * Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: * Participation in any investigational drug study within 4 weeks preceding the start of study treatment; * Age ≤18 or ≥75 years of Age; * Pregnant or breastfeeding women; * Serious, uncontrolled, concurrent infection(s) requiring antibiotics; * Clinically apparent central nervous system metastases or carcinomatous meningitis; * Treatment for other carcinomas within the last 3 months; * Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory; * Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.
References
Publications (0)
Data not yet available