Nasopharyngeal CarcinomaPhase 2NCT05232552
Study of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Anlotinib hydrochloride, induction chemotherapy and concurrent chemoradiation in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Anlotinib hydrochloride, induction chemotherapy and concurrent chemoradiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
feng jiang, +86 571 88128201, jiangfeng@zjcc.org.cn
xiaozhong Chen
About this study
Official title: Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Anlotinib hydrochloride, induction chemotherapy, concurrent chemoradiation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
anlotinib was administered orally 12mg daily for 14 days concurrent with inductive chemotherapy (TP ) for 3 cycles and definitive chemoradiation for additional 2 cycles
induction chemotherapyDrug
Also called IC
docetaxel 75mg/m2 d1 plus DDP 75mg/m2 d1 for 3 cycles every 21days
concurrent chemoradiationRadiation
Also called CCRT
definitive IMRT (GTV>66Gy) concurrent with 2 cycles of DDP (100mg/m2 d1) and anlotinib (12mg d1-14) every 21 days
| Study group | Role | What they receive |
|---|---|---|
| anlotinib | Experimental | 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) Receives: Drug: Anlotinib hydrochloride; Drug: induction chemotherapy; Radiation: concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
tumor objective response rate
Measured: induction phase ; 3 months after chemoradiation
Secondary outcomes (3)
PFS
progression-free survival
Measured: 3year
LRR
local relapse rate
Measured: 3 years
RRR
regional relapse rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaozhong, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232552
- Sponsor's protocol ID
- NPC-anlotinib 1
- Status last verified
- May 2021
- First submitted
- 23 May 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD could be shared with reasonable reasons
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
- ClinicalTrials.gov ID
- NCT05232552
- Acronym / sponsor ID
- NPC-anlotinib 1
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib | Experimental | Drug: Anlotinib hydrochloride, Drug: induction chemotherapy, Radiation: concurrent chemoradiation3 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib hydrochlorideanlotinib was administered orally 12mg daily for 14 days concurrent with inductive chemotherapy (TP ) for 3 cycles and definitive chemoradiation for additional 2 cycles | Drug | anlotinib |
| induction chemotherapyAlso: ICdocetaxel 75mg/m2 d1 plus DDP 75mg/m2 d1 for 3 cycles every 21days | Drug | anlotinib |
| concurrent chemoradiationAlso: CCRTdefinitive IMRT (GTV>66Gy) concurrent with 2 cycles of DDP (100mg/m2 d1) and anlotinib (12mg d1-14) every 21 days | Radiation | anlotinib |
Primary outcome
ORR
Time frame: induction phase ; 3 months after chemoradiation
tumor objective response rate
3 secondary outcomes
PFS
Time frame: 3year
LRR
Time frame: 3 years
RRR
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No. IPD could be shared with reasonable reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib hydrochloride, induction chemotherapy and concurrent chemoradiation in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact feng jiang (0571-88128202, jiangfeng@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: induction phase ; 3 months after chemoradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.