Nasopharyngeal CarcinomaPhase 3NCT03601975
Gemcitabine and Cisplatin With/Without Anlotinib in Advanced Nasopharyngeal Carcinoma
A Phase 3 study testing Gemcitabine/Cisplatin in people with Nasopharyngeal Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a Phase III randomized controlled multi-center trial comparing anlotinib plus Gemcitabine/Cisplatin with placebo plus Gemcitabine/Cisplatin in previous untreated patients with recurrent/metastatic Nasopharyngeal Carcinoma, in order to verify the efficacy and security of anlotinib in mNPC patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Gemcitabine/Cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2018to 30 Jul 2021
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed of the investigational nature of this study and give written informed consent
- Histologically or cytologically confirmed nasopharyngeal carcinoma, tumor staged as IVB (according to the 8th AJCC edition) or recurrent tumor nott suitable for local treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to1, life expectancy of at least 12 weeks.
- Antitumor therapy naive for recurrent or metastatic nasopharyngeal carcinoma
- Completed radiotherapy for local tumor 4 weeks before the enrollment
- Measurable disease other than brain metastasis based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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- Adequate organ system function, defined as follows:
- ANC ≥1.5×109/L, PLT ≥100×109/L, Hb）≥90g /L;
- TBIL ≤ 1.5×ULN；Aminopherases (ALT and AST) ≤ 2.5 × ULN (without liver metastasis) or ≤ 5.0 × ULN (with liver metastasis), Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml/min;
- Urine protein < ++，or urine protein ≥ ++ concomitant with content of -hour urinary protein <1.0 g;
- INR≤1.5×ULN, APTT≤1.5×ULN;
- LVEF ≥50%;
- Women who are not of child-bearing potential, and women of child-bearing potential who have a negative serum or urine pregnancy test prior to initial trial treatment, and who agree to use adequate contraceptive measures during the study; Men with partners of childbearing potential willing to use adequate contraceptive measures during the study
Who cannot join
- Patients with a previous malignancy within the past 5 years (other than curatively treated in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma).
- Allergic to anotinib or the chemotherapeutic agents involved in this trial;
- Supposed to receive locally treatment (except for those with symptomatic bone metastases receive appropriate local doses radiotherapy which does not affect the hemogram)
- Patients that have received definitive radiotherapy, adjuvant chemotherapy or cocurrent chemoradiotherapy for stage I-IVA and developed recurrent disease within 6 months;
- Patients that have previously received target therapies;
- Patients that have previously received immunotherapy (i.e.,interferon, or IL-2 ) 28 days before randomization or within 5 half-life of the drug.
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- Patients that have previously received immunosupressive drugs (i.e., Corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide or TNF-α)
- Symptomatic CNS metastasis (i.e. encephaledema, hormone intervention, or brain metastasis progression)
- Patients currently have bleeding tendency, including but not limited to gastrointestinal bleeding, nasal bleeding, hemoptysis, and persistent bleeding or coagulopathy;
- Hemoptysis (defined as coughing out or spitting out ≥ 1 teaspoon of blood or small blood clots or hemoptysis without sputum) within 28 days before randomization, not including bloody sputum.
- Radiograph (within 28 days before randomization) showed that the tumor surrounded important blood vessels, and the investigators determined that entering the study would cause bleeding risk;
- Subjects have any of the following severe acute complications:
- Unstable angina and/or congestive heart failure or vascular disease (eg, aortic aneurysm requires surgically repaired or peripheral venous thromboembolism) requiring hospitalization within 12 months, or other cardiac impairments (eg,uncontrolled arrhythmias) determined by the investigator, which may affect the evaluation of drug safety; Myocardial infarction or ischemia with ST elevation ≥ 2 mm indicated by ECG;
- Arterial thromboembolism, venous thromboembolism in grade 3 or higher (according to NCI-CTCAE), transient ischemic attack (TIA), cerebral vascular accident (CVA), transmural myocardial infarction ( MI), hypertensive crisis or hypertensive encephalopathy within 24weeks;
- Chronic Obstructive Pulmonary Disease (COPD) or other respiratory diseases requiring hospitalization within 28 days before randomization;
- Abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding within 24 weeks before randomization;
- Esophageal and gastric varices, unhealed ulcers, unhealed wounds or fracture within 24 weeks before randomization;
- Pulmonary infections and/or acute bacterial or fungal infections requiring intravenous antibiotic therapy
- Clinical jaundice and/or coagulation disorders caused by liver dysfunction;
- Minor surgical procedures (including catheterization, excluding peripheral venipuncture central vena catheterization) within 2 days of randomization;
- The virological test indicates that either of the following 28 days before randomization
- HBsAg positive and HBV DNA ≥ 1 × 103 copies/L;
- Anti-HCV positive
- HIV positive
- Participation of an anti-tumor clinic trial within 28 days before randomization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
651 Dongfeng Road East, Yuexiu District, Guanzhou, P.R. China
Guangzhou, Guangdong, 510060
Li Zhang, doctor, 020-87343458, zhangli@sysucc.org.cn
About this study
Official title: Phase III Randomized Trial of Anlotinib Plus Gemcitabine/Cisplatin Vesus Placebo Plus Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
This is a Phase III randomized controlled multi-center trial comparing anlotinib plus Gemcitabine/Cisplatin with placebo plus Gemcitabine/Cisplatin in previous untreated patients with recurrent/metastatic Nasopharyngeal Carcinoma, in order to verify the efficacy and security of anlotinib in mNPC patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Gemcitabine/Cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/CisplatinDrug
gemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle
| Study group | Role | What they receive |
|---|---|---|
| anlotinib plus Gemcitabine/Cisplatin | Experimental | patients receive anlotinib at 12mg QD (d1-d14)and gemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle Receives: Drug: Gemcitabine/Cisplatin |
| placebo plus Gemcitabine/Cisplatin | Placebo comparator | patients receive pacebo at 0mg QD (d1-d14)and gemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle Receives: Drug: Gemcitabine/Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progeression free survival is calculated from randomization to disease progeression or death
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start27 Aug 2018
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601975
- Sponsor's protocol ID
- ALTN-17-III
- Status last verified
- Feb 2019
- First submitted
- 17 Jul 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao Z, Chen W, Du Y, Zeng F, Su F, Huang S, Qu S. Efficacy and safety of Anlotinib in combination with gemcitabine and cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A single-arm clinical trial. Int J Cancer. 2025 Jun 1;156(11):2169-2177. doi: 10.1002/ijc.35340. Epub 2025 Jan 18.
PubMed 39825777
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of Anlotinib Plus Gemcitabine/Cisplatin Vesus Placebo Plus Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03601975
- Acronym / sponsor ID
- ALTN-17-III
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 26 Jul 2018 (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.
This is a Phase III randomized controlled multi-center trial comparing anlotinib plus Gemcitabine/Cisplatin with placebo plus Gemcitabine/Cisplatin in previous untreated patients with recurrent/metastatic Nasopharyngeal Carcinoma, in order to verify the efficacy and security of anlotinib in mNPC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anlotinib plus Gemcitabine/Cisplatin | Experimental | Drug: Gemcitabine/Cisplatinpatients receive anlotinib at 12mg QD (d1-d14)and gemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle |
| placebo plus Gemcitabine/Cisplatin | Placebo comparator | Drug: Gemcitabine/Cisplatinpatients receive pacebo at 0mg QD (d1-d14)and gemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed of the investigational nature of this study and give written informed consent
- Histologically or cytologically confirmed nasopharyngeal carcinoma, tumor staged as IVB (according to the 8th AJCC edition) or recurrent tumor nott suitable for local treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to1, life expectancy of at least 12 weeks.
- Antitumor therapy naive for recurrent or metastatic nasopharyngeal carcinoma
- Completed radiotherapy for local tumor 4 weeks before the enrollment
Key exclusion criteria (25 listed)
- Patients with a previous malignancy within the past 5 years (other than curatively treated in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma).
- Allergic to anotinib or the chemotherapeutic agents involved in this trial;
- Supposed to receive locally treatment (except for those with symptomatic bone metastases receive appropriate local doses radiotherapy which does not affect the hemogram)
- Patients that have received definitive radiotherapy, adjuvant chemotherapy or cocurrent chemoradiotherapy for stage I-IVA and developed recurrent disease within 6 months;
- Patients that have previously received target therapies;
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 |
|---|---|---|
| Gemcitabine/Cisplatingemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle | Drug | anlotinib plus Gemcitabine/Cisplatin, placebo plus Gemcitabine/Cisplatin |
Primary outcome
PFS
Time frame: 12months
Progeression free survival is calculated from randomization to disease progeression or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 39825777Xiao Z, Chen W, Du Y, Zeng F, Su F, Huang S, Qu S. Efficacy and safety of Anlotinib in combination with gemcitabine and cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A single-arm clinical trial. Int J Cancer. 2025 Jun 1;156(11):2169-2177. doi: 10.1002/ijc.35340. Epub 2025 Jan 18.
- Individual participant dataSharing planned: No
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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.
651 Dongfeng Road East, Yuexiu District, Guanzhou, P.R. China
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine/Cisplatin in people with Nasopharyngeal Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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 13 inclusion and 25 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 4 Feb 2019. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03601975, which also lists 1 linked publication.
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 4 Feb 2019.