Clinical trial · Interventional
Study of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma
Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
NCT05232552CI-TRIAL-00056468unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM
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 Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib hydrochloride | Drug | — | UNRESOLVED |
| concurrent chemoradiation | Radiation | — | UNRESOLVED |
| induction chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anlotinib
- description
- 3 cycles of anlotinib (12mg, d1-14)was given concurrently with docetaxel plus cisplatin chemotherapy as induction , then 2 additional cycles of anlotinib concurrent with definitive chemoradiation (IMRT with conccurent cisplatin)
- interventionNames
- Drug: Anlotinib hydrochloride
- Drug: induction chemotherapy
- Radiation: concurrent chemoradiation
Primary outcomes (1)
- measure
- ORR
- timeFrame
- induction phase ; 3 months after chemoradiation
- description
- tumor objective response rate
Secondary outcomes (3)
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ; 2. N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM; 3. with sufficient organ and bone marrow function; 4. ECOG (Eastern US Cooperative Oncology Group) score \< 3 5. with good compliance and cooperation to treatment and follow-up 6. agree to use effective methods of contraception during the study period and within 180 days of the last study administration. Exclusion Criteria: 1. patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\] 2. patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture; 3. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C. 4. Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin \>38.5℃ 1 weeks ago (except for tumor related fever determined by researchers). 5. Abnormal coagulation (INR \> 1.5 or APTT \> 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation. Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required. 6. serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study 7. Allergy to the drugs in the study
References
Publications (0)
Data not yet available
No reference posted for this study.