Locally Advanced Nasopharyngeal CarcinomaPhase 2NCT05397769
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
A Phase 2 study testing Envafolimab Plus Chemoradiotherapy in people with Locally Advanced Nasopharyngeal Carcinoma and Envafolimab, run by Sun Yat-sen University at 1 site in China.
Trial summary
Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma, Envafolimab, Induction Chemotherapy
- What is being tested?
- Envafolimab Plus Chemoradiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2022to 31 Dec 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG 0-1
- histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx
- stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients
- NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
- ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
- creatinine<1.5×ULN
Who cannot join
- recurrent or metastatic NPC patients
- histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx
- already received radiation or chemotherapy
- pregnant or lactating women, or women of childbearing age without birth control
- HIV (+)
- had other cancers before
Show all 17Show fewer
- used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before
- complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose
- with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)
- use of massive dose of glucocorticoids within 4 weeks before enrollment
- laboratory test values do not meet relevant standards within 7 days before enrollment
- significantly lower functions of heart, liver, lung, kidney and bone marrow
- serious or uncontrolled medical diseases or infections
- participating other clinical trial in the same time
- HBsAg (+) and HBV DNA >1×10E3 copiers /mL
- HCV (+) unless HCV RNA PCR(-)
- with any other treatment contraindications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fei Han, 13822113698 ext. 86, hanfei@sysucc.org.cn
Fei Han, MD
About this study
Official title: Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.
- Being tested
- Envafolimab Plus Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab Plus ChemoradiotherapyDrug
Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab group | Experimental | Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy. Receives: Drug: Envafolimab Plus Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression free survival
time from the randomization to the first disease progression or death
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start8 Jun 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Han, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397769
- Sponsor's protocol ID
- B2022-203-01
- Status last verified
- Aug 2022
- First submitted
- 26 May 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
- ClinicalTrials.gov ID
- NCT05397769
- Acronym / sponsor ID
- B2022-203-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 May 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.
Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab group | Experimental | Drug: Envafolimab Plus ChemoradiotherapyEnvafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG 0-1
- histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx
- stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients
- NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
- ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
Key exclusion criteria (17 listed)
- recurrent or metastatic NPC patients
- histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx
- already received radiation or chemotherapy
- pregnant or lactating women, or women of childbearing age without birth control
- HIV (+)
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 |
|---|---|---|
| Envafolimab Plus ChemoradiotherapyEnvafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy. | Drug | Envafolimab group |
Primary outcome
3-year progression free survival
Time frame: 3-year
time from the randomization to the first disease progression or death
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 10 Aug 2022.
- 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.
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 Envafolimab Plus Chemoradiotherapy in people with Locally Advanced Nasopharyngeal Carcinoma and Envafolimab, run by Sun Yat-sen University 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 17 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: looking for participants now, as of the sponsor's last update on 10 Aug 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?
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?
Contact Fei Han (13822113698 ext. 86, hanfei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression free survival (time frame: 3-year). 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 Aug 2022.