Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
Brief Summary
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ;
- •N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM;
- •with sufficient organ and bone marrow function;
- •ECOG (Eastern US Cooperative Oncology Group) score < 3
- •with good compliance and cooperation to treatment and follow-up
- •agree to use effective methods of contraception during the study period and within 180 days of the last study administration.
Exclusion Criteria
- •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)]
- •patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture;
- •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.
- •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).
- •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.
- •serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study
- •Allergy to the drugs in the study
Arms & Interventions
anlotinib
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)
Intervention: Anlotinib hydrochloride (Drug)
anlotinib
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)
Intervention: induction chemotherapy (Drug)
anlotinib
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)
Intervention: concurrent chemoradiation (Radiation)
Outcomes
Primary Outcomes
ORR
Time Frame: induction phase ; 3 months after chemoradiation
tumor objective response rate
Secondary Outcomes
- PFS(3year)
- LRR(3 years)
- RRR(3 years)
Investigators
Chen Xiaozhong
Director, Head of Radiation department, Principal Investigator, Clinical Professor
Zhejiang Cancer Hospital