Clinical trial · Interventional
Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma
A Phase II Randomized Trial of Efficacy and Safety of Particle Therapy With or Without Apatinib as Induction Therapy for Treatment of Head and Neck Adenoid Cystic 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)
It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.
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 |
|---|---|---|---|
| Adenoid Cystic Carcinoma | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Particle Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib with Particle Therapy
- description
- Participants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
- interventionNames
- Drug: Apatinib
- Radiation: Particle Therapy
- type
- EXPERIMENTAL
- label
- Particle Therapy
- description
- Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
- interventionNames
- Radiation: Particle Therapy
Primary outcomes (1)
- measure
- Short-term treatment response of all patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed ACC * Inoperable disease or postoperative residual disease detected by imaging studies * Age ≥ 18 and ≤ 65 years of age * ECOG \< 2, no significant active concurrent medical illnesses * Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \> 2000/mm\^3; PLT \> 100,000/mm\^3; total bilirubin \< 1.5mg/dl; AST/ALT \< 1.5 ULN; SCr \< 1.5mg/dl; CCR \> 60ml/min * Willing to accept adequate contraception for women with childbearing potential * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: * Presence of distant metastasis * Pregnant or lactating women * A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years * Refusal of the patient to participate into the study
References
Publications (0)
Data not yet available