Nasopharyngeal CarcinomaPhase 2NCT06055816
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Endostar and Envafolimab in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Endostar and Envafolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥65 years with newly pathologically confirmed NPC
- ECOG score: 0 to 1.
- Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition)
- Adequate organ function
Who cannot join
- HBsAg positive with a hepatitis B virus quantification > 1×10³ copies/mL or anti-HCV positive.
- Anti-HIV positive or AIDS diagnosis
- Active tuberculosis: within the past year.
- Active or suspected autoimmune diseases (e.g., uveitis, enteritis, hepatitis), excluding stable type I diabetes, treated hypothyroidism, or mild skin conditions
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within the past year.
- Chronic systemic glucocorticoids or immunosuppressive therapy (≥10 mg prednisone/day); inhaled/topical corticosteroids permitted.
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- Uncontrolled cardiovascular disease (e.g., New York Heart Association [NYHA] ≥ II heart failure, recent myocardial infarction, unstable angina, significant arrhythmias).
- History of other malignancies (except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or papillary thyroid cancer).
- Known allergy to envafolimab or its components.
- Active infection within a week requiring systemic therapy.
- Receiving a live vaccine within 30 days prior to first envafolimab dose
- History of organ transplantation.
- Any condition deemed by investigators to interfere with safety or protocol adherence (e.g., serious comorbidity, severe lab abnormalities, or psychosocial issues).
Trial locations and contacts
1 site in 1 country.
About this study
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Endostar and Envafolimab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostar and EnvafolimabDrug
Neoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine Combined With Endostar and Envafolimab | Experimental | Neoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy. Receives: Drug: Endostar and Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with grade 3 or higher adverse events (AEs).
The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start24 Oct 2023
- Primary completion9 May 2026
- Study completion30 Jun 2028 (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
- 40 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
- Investigators
- Xiaozhong Chen, Principal investigator, Department of Radiation Oncology, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055816
- Sponsor's protocol ID
- GEE study
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06055816
- Acronym / sponsor ID
- GEE study
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 9 May 2026 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Sep 2023 (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.
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine Combined With Endostar and Envafolimab | Experimental | Drug: Endostar and EnvafolimabNeoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged ≥65 years with newly pathologically confirmed NPC
- ECOG score: 0 to 1.
- Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition)
- Adequate organ function
Key exclusion criteria (13 listed)
- HBsAg positive with a hepatitis B virus quantification > 1×10³ copies/mL or anti-HCV positive.
- Anti-HIV positive or AIDS diagnosis
- Active tuberculosis: within the past year.
- Active or suspected autoimmune diseases (e.g., uveitis, enteritis, hepatitis), excluding stable type I diabetes, treated hypothyroidism, or mild skin conditions
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within the past year.
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 |
|---|---|---|
| Endostar and EnvafolimabNeoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy. | Drug | Gemcitabine Combined With Endostar and Envafolimab |
Primary outcome
The proportion of patients with grade 3 or higher adverse events (AEs).
Time frame: Up to 24 weeks
The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaozhong Chen principal investigator
Department of Radiation Oncology, Zhejiang Cancer Hospital
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 Endostar and Envafolimab 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of patients with grade 3 or higher adverse events (AEs). (time frame: Up to 24 weeks). 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 6 Oct 2026.