Nasopharyngeal CarcinomaPhase 2NCT04350190
Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Apatinib mesylate tablet and PD-1 in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 5 sites in China.
Trial summary
The study is to evaluate the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including The Overall Response Rate (ORR), Progression-free survival (PFS),Overall survival (OS),and Toxicities. 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?
- Apatinib mesylate tablet and PD-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesChina
- Study dates
- 14 Jan 2021to 15 Sep 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients: 18-70 years old.
- Pathologically diagnosed nasopharyngeal carcinoma.
- Patients with nasopharyngeal carcinoma who have local recurrence after one comprehensive treatment (clinical examination found definite local residual: clear residual or cervical enlarged lymph node can be seen under electronic nasopharyngoscope).
- Patients with nasopharyngeal carcinoma who have distant metastasis after one comprehensive treatment (found distant metastasis by liver ultrasound, chest X-ray, bone scan or other examination (such as CT, MRI or PET/CT) as the clinician considers appropriate.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Estimated survival ≥6 months.
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- The function of the main organs is good, that is, one week before joining the group, the following requirements are met:
- Blood routine examination:Hemoglobin > 80 g/L(no blood transfusion within 14 days);Neutrophils count > 1.5x10^9/L;Platelet count > 80x10^9/L; biochemical test:serum total bilirubin ≤1.5×ULN(upper limit of normal), ALT or AST≤3×ULN;Endogenous creatinine clearance ≥ 1.5×ULN;Acceptable clotting state: the international standardized ratio ((INR)), prothrombin time (PT) and activated partial thromboplastin time (APTT) of blood clots were less than 1.5 times of the upper limit of normal (ULN).
- All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Who cannot join
- Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery / vein), or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.
- There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE4.0 occurred within 4 weeks before screening.
- Patients with hypertension who cannot be well controlled by antihypertensive therapy alone (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); patients with a history of unstable angina pectoris; patients newly diagnosed with angina pectoris within 3 months or myocardial infarction within 6 months before screening; arrhythmias (including QTcF: ≥ 450ms in males, ≥ 470ms in females) require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency.
- Positive urine protein.
- Patients with abnormal blood coagulation and bleeding tendency (14 days before signing informed consent: INR is within the normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; On the premise that the international standardized ratio of prothrombin time ((INR)) is less than 1.5, low-dose warfarin (1mg orally, once a day) or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive purposes.
- Arteriovenous thrombosis occurred within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by intravenous catheterization due to early chemotherapy) and pulmonary embolism.
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- Long-term unhealed wound or incomplete fracture.
- Any factors that affect the oral drug, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.
- For female subjects: women of childbearing age, it is not acceptable to use medically approved contraception during the study treatment period and within 6 months after the end of the study treatment period;Patients with positive serum or urine pregnancy test;Nursing patients.Male subjects: patients who did not undergo surgical sterilization or did not agree to use medically approved contraception during the study and within 6 months after the study.
- Having a history of psychotropic substance abuse and unable to quit or having mental disorders.
- Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.Any symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) that requires administration of >10mg of prednisone equivalent. Lower dose steroids for conditions such as hypophysitis are allowed.
- Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
- Any prior severe adverse event attributed to prior anti-PD1 therapy that, in the Principal investigator's opinion, would contraindicate pembrolizumab administration such as:Grade 2 or higher pneumonitis、Grade 4 AST or ALT elevation、Grade 3 or higher colitis; Known active infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV. Cleared HBV/HCV infection is not an exclusion, nor is HIV infection with cluster of differentiations 4 (CD4) counts >500 and an undetectable viral load.
- Active bacterial, viral, or fungal infections, requiring systemic therapy apart from anti-viral maintenance therapy for HIV；or Uncontrolled activity infected.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Guilin Medical University
Guilin, Guangxi
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi
People's Hospital of Laibin
Laibin, Guangxi
People's Hospital of Lingshan
Linshan, Guangxi
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
About this study
Official title: A Prospective Multicenter Phase II Clinical Trial of Apatinib Mesylate Tablets Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
The study is to evaluate the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including The Overall Response Rate (ORR), Progression-free survival (PFS),Overall survival (OS),and Toxicities.
Read the detailed description
PRIMARY OBJECTIVES:
To determine the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma.
SECONDARY OBJECTIVES:
Ⅰ.To explore the adjuvant medication regimen of recurrent and metastatic nasopharyngeal carcinoma.
Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment strategy of nasopharyngeal carcinoma patients.
OUTLINE:
Eligible patients begin to use apatinib mesylate tablets and PD-1, apatinib mesylate tablets at the recommended dose of 250mg,orally, QD, continuous administration, 4 weeks (28 days) as an observation cycle. Until the disease progressed or unbearable adverse reactions appeared. If missed medication occurs during the medication period, it is confirmed that the next medication time is less than 12 hours, then there will be no replenishment. The recommended dose of PD-1 is 200mg/time, Q2W, intravenous injection, 4 weeks (28 days) as an observation cycle, until disease progression or intolerable toxicity.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Apatinib mesylate tablet, PD-1
- Keywords
- Nasopharyngeal Carcinoma, Apatinib, PD-1, Second-line treatment, Overall response rate
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib mesylate tabletDrug
The dose of apatinib mesylate tablets is 250mg, oral, qd, continuous administration, 4 weeks (28 days) as an observation cycle.
PD-1Drug
The dose of PD - 1 is 200 mg/ time, intravenous injection, q2w, 4 weeks (28 days) for an observation period.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib combined with PD-1 | Experimental | Eligible patients begin to use apatinib mesylate tablets and PD-1, apatinib mesylate tablets at the recommended dose of 250mg,oral, QD, continuous administration, 4 weeks (28 days) as an observation cycle. Until the disease progressed or unbearable adverse reactions appeared. If missed medication occurs during the medication period, it is confirmed that the next medication time is less than 12 hours, then there will be no replenishment. The recommended dose of PD-1 is 200mg/time, Q2W, intravenous injection, 4 weeks (28 days) as an observation cycle, until disease progression or intolerable toxicity. Receives: Drug: Apatinib mesylate tablet; Drug: PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
To evaluate ORR every 6-8 weeks after initiation of treatment.
Measured: Up to 24 months
Secondary outcomes (3)
Progression-free survival (PFS)
The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death
Measured: Up to 24 months
Overall survival (OS)
The time from the first day of therapy to death or last follow-up
Measured: Up to 24 months
Number of Participants with Adverse Events
Incidence of acute and late toxicity
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start14 Jan 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
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.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Guangxi Naxishan Hospital, Laibin People's Hospital, People's Hospital of Lingshan
- Responsible party
- Sponsor-investigator, Wei Jiang, Guilin Medical University, China
- Investigators
- Wei Jiang, Ph.D., Study director, Guilin Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350190
- Sponsor's protocol ID
- GLMU-06
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mo Y, Pan Y, Zhang B, Zhang J, Su Y, Liu Z, Luo M, Qin G, Kong X, Zhang R, Pan Y, Liang Y, Wang D, Wei Y, Chen H, Jiang W. Apatinib combined with camrelizumab in the treatment of recurrent/metastatic nasopharyngeal carcinoma: a prospective multicenter phase II study. Front Immunol. 2024 Jan 3;14:1298418. doi: 10.3389/fimmu.2023.1298418. eCollection 2023.
PubMed 38239359
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Phase II Clinical Trial of Apatinib Mesylate Tablets Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04350190
- Acronym / sponsor ID
- GLMU-06
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Apatinib, PD-1, Second-line treatment, Overall response rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wei JiangUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Guangxi Naxishan Hospital, Laibin People's Hospital, People's Hospital of Lingshan
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 16 Apr 2020 (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.
The study is to evaluate the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including The Overall Response Rate (ORR), Progression-free survival (PFS),Overall survival (OS),and Toxicities.
Detailed description
PRIMARY OBJECTIVES:
To determine the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma.
SECONDARY OBJECTIVES:
Ⅰ.To explore the adjuvant medication regimen of recurrent and metastatic nasopharyngeal carcinoma.
Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment strategy of nasopharyngeal carcinoma patients.
OUTLINE:
Eligible patients begin to use apatinib mesylate tablets and PD-1, apatinib mesylate tablets at the recommended dose of 250mg,orally, QD, continuous administration, 4 weeks (28 days) as an observation cycle. Until the disease progressed or unbearable adverse reactions appeared. If missed medication occurs during the medication period, it is confirmed that the next medication time is less than 12 hours, then there will be no replenishment. The recommended dose of PD-1 is 200mg/time, Q2W, intravenous injection, 4 weeks (28 days) as an observation cycle, until disease progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib combined with PD-1 | Experimental | Drug: Apatinib mesylate tablet, Drug: PD-1Eligible patients begin to use apatinib mesylate tablets and PD-1, apatinib mesylate tablets at the recommended dose of 250mg,oral, QD, continuous administration, 4 weeks (28 days) as an observation cycle. Until the disease progressed or unbearable adverse reactions appeared. If missed medication occurs during the medication period, it is confirmed that the next medication time is less than 12 hours, then there will be no replenishment. The recommended dose of PD-1 is 200mg/time, Q2W, intravenous injection, 4 weeks (28 days) as an observation cycle, until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients: 18-70 years old.
- Pathologically diagnosed nasopharyngeal carcinoma.
- Patients with nasopharyngeal carcinoma who have local recurrence after one comprehensive treatment (clinical examination found definite local residual: clear residual or cervical enlarged lymph node can be seen under electronic nasopharyngoscope).
- Patients with nasopharyngeal carcinoma who have distant metastasis after one comprehensive treatment (found distant metastasis by liver ultrasound, chest X-ray, bone scan or other examination (such as CT, MRI or PET/CT) as the clinician considers appropriate.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (14 listed)
- Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery / vein), or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.
- There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE4.0 occurred within 4 weeks before screening.
- Patients with hypertension who cannot be well controlled by antihypertensive therapy alone (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); patients with a history of unstable angina pectoris; patients newly diagnosed with angina pectoris within 3 months or myocardial infarction within 6 months before screening; arrhythmias (including QTcF: ≥ 450ms in males, ≥ 470ms in females) require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency.
- Positive urine protein.
- Patients with abnormal blood coagulation and bleeding tendency (14 days before signing informed consent: INR is within the normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; On the premise that the international standardized ratio of prothrombin time ((INR)) is less than 1.5, low-dose warfarin (1mg orally, once a day) or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive purposes.
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 |
|---|---|---|
| Apatinib mesylate tabletThe dose of apatinib mesylate tablets is 250mg, oral, qd, continuous administration, 4 weeks (28 days) as an observation cycle. | Drug | Apatinib combined with PD-1 |
| PD-1The dose of PD - 1 is 200 mg/ time, intravenous injection, q2w, 4 weeks (28 days) for an observation period. | Drug | Apatinib combined with PD-1 |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 24 months
To evaluate ORR every 6-8 weeks after initiation of treatment.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Number of Participants with Adverse Events
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Derived from this study: PubMed 38239359Mo Y, Pan Y, Zhang B, Zhang J, Su Y, Liu Z, Luo M, Qin G, Kong X, Zhang R, Pan Y, Liang Y, Wang D, Wei Y, Chen H, Jiang W. Apatinib combined with camrelizumab in the treatment of recurrent/metastatic nasopharyngeal carcinoma: a prospective multicenter phase II study. Front Immunol. 2024 Jan 3;14:1298418. doi: 10.3389/fimmu.2023.1298418. eCollection 2023.
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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.
Wei Jiang, Ph.D. study director
Guilin Medical University, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib mesylate tablet and PD-1 in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 5 sites 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 24 months). 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 NCT04350190, 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 13 Jan 2023.