Nasopharyngeal CarcinomaPhase 2NCT04143984
Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Induction chemotherapy, Carbon-ion radiotherapy and Camrelizumab in people with Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus… 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?
- Induction chemotherapy, Carbon-ion radiotherapy and Camrelizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2021to 20 Dec 2025
- 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
- Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy
- Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT
- Patients with neck lymphadenopathy should receive neck dissection before randomization
- With measurable lesion on contrast MR scan
- Age ≥ 18 and < 70 years of age
- ECOG score: 0-1
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- Leucocyte count ≥ 4000/µL, neutrocyte count ≥ 2000/µL, platelet count ≥ 100000/µL, hemoglobin ≥ 90g/L
- Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN), alkaline phosphatase < 2.5×ULN, bilirubin ≤ ULN, serum creatinine ≤ ULN, creatinine clearance ≥ 60ml/min
- Willing to accept adequate contraception
- Ability to understand the nature of the clinical trial and sign the written informed consent
Who cannot join
- Presence of distant metastasis
- Previously received radioactive particle implantation
- Prior malignancy within 5 years before randomization, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer
- Patients who received local (such as surgery and cryotherapy) or systemic treatment, except for induction chemotherapy after diagnosis of recurrence
- With uncontrolled active infection
- With pneumonia
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- With autoimmune disease
- With a known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Hepatitis B virus (HBV) DNA ≥ 500IU/mL for patients with positive HBV surface antigen, positive hepatitis C virus RNA for patients with positive HCV antigen
- Previously treated by immune checkpoint inhibitors
- Medical conditions requiring treatment of antibiotics and/or corticosteroid
- Treated with ≥ 5 days antibiotics one month before start of immunotherapy
- With known allergy to any of the study drugs
- Pregnant or lactating women
- Any severe intercurrent disease that may interfere with the current study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
Jiyi Hu, MD, PhD, +8602138296666 ext. 53513, jiyi.hu@sphic.org.cn
Lin Kong, MD, +8602138296666 ext. 53516, konglin@sphic.org.cn
About this study
Official title: A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma
The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).
Read the detailed description
Treatment for locally recurrent nasopharyngeal carcinoma (LR-NPC) is challenging. Carbon-ion radiotherapy appeared to be an effective treatment for this group of patients, and has substantially improved the 2-year overall survival (OS) to approximately 85%, compared to photon-based intensity-modulated radiotherapy. However, a group of the patients may still develop disease progression after CIRT, and the 2-year progression-free survival (PFS) was approximately 45%-50%. Camrelizumab, a programmed cell death 1 (PD-1) inhibitor, has been demonstrated that it is effective in the recurrent/metastatic nasopharyngeal carcinoma; however, the role of camrelizumab in concurrence with radiotherapy, especially CIRT, for LR-NPC is not clear. The purpose of this phase 2 clinical trial is to compare the efficacy of CIRT plus camrelizumab and CIRT alone in the treatment of LR-NPC. Eligible participants will be randomized (1:1) to 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group). The primary endpoint is progression-free survival. Secondary endpoints include overall survival (OS), local progression-free survival (LPFS), regional progression-free survival (RPFS), and distant metastasis-free survival (DMFS) and toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Induction chemotherapy, Carbon-ion radiotherapy, Camrelizumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemotherapyDrug
Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.
Carbon-ion radiotherapyRadiation
Accelerated carbon-ion beam with pencil beam scanning technique.
CamrelizumabDrug
Also called SHR-1210
An anti-PD-1 antibody.
| Study group | Role | What they receive |
|---|---|---|
| Arm-C | Active comparator | Patients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE). Receives: Drug: Induction chemotherapy; Radiation: Carbon-ion radiotherapy |
| Arm-CC | Experimental | Patients will receive induction chemotherapy followed by carbon-ion radiotherapy and camrelizumab. In details, patients will receive carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE); in addition, patients will also receive camrelizumab of 200 mg (IV.), every 2 weeks, started with carbon-ion radiotherapy for a maximal period of 1 year. Receives: Drug: Induction chemotherapy; Radiation: Carbon-ion radiotherapy; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.
Measured: 2-year
Secondary outcomes (5)
Overall survival
Duration from randomization to death from any cause.
Measured: 2-year
Local progression-free survival
Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.
Measured: 2-year
Regional progression-free survival
Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.
Measured: 2-year
Distant metastasis-free survival
Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.
Measured: 2-year
Number of participants with adverse events
Incidence of adverse events
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start19 Jan 2021
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiade J. Lu, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade J Lu, MD, Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143984
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2019-34
- Status last verified
- Apr 2022
- First submitted
- 27 Oct 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on participants' clinical features, treatment modalities, survivals and toxicity profile will be shared upon reasonable request. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.
Publications
Hu J, Huang Q, Hu W, Gao J, Yang J, Zhang H, Lu JJ, Kong L. A protocol for a randomized trial evaluating the role of carbon-ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma. Cancer Med. 2024 Feb;13(3):e6742. doi: 10.1002/cam4.6742. Epub 2024 Jan 11.
PubMed 38205914
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04143984
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2019-34
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 30 Oct 2019 (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 purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).
Detailed description
Treatment for locally recurrent nasopharyngeal carcinoma (LR-NPC) is challenging. Carbon-ion radiotherapy appeared to be an effective treatment for this group of patients, and has substantially improved the 2-year overall survival (OS) to approximately 85%, compared to photon-based intensity-modulated radiotherapy. However, a group of the patients may still develop disease progression after CIRT, and the 2-year progression-free survival (PFS) was approximately 45%-50%. Camrelizumab, a programmed cell death 1 (PD-1) inhibitor, has been demonstrated that it is effective in the recurrent/metastatic nasopharyngeal carcinoma; however, the role of camrelizumab in concurrence with radiotherapy, especially CIRT, for LR-NPC is not clear. The purpose of this phase 2 clinical trial is to compare the efficacy of CIRT plus camrelizumab and CIRT alone in the treatment of LR-NPC. Eligible participants will be randomized (1:1) to 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group). The primary endpoint is progression-free survival. Secondary endpoints include overall survival (OS), local progression-free survival (LPFS), regional progression-free survival (RPFS), and distant metastasis-free survival (DMFS) and toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-C | Active comparator | Drug: Induction chemotherapy, Radiation: Carbon-ion radiotherapyPatients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE). |
| Arm-CC | Experimental | Drug: Induction chemotherapy, Radiation: Carbon-ion radiotherapy, Drug: CamrelizumabPatients will receive induction chemotherapy followed by carbon-ion radiotherapy and camrelizumab. In details, patients will receive carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE); in addition, patients will also receive camrelizumab of 200 mg (IV.), every 2 weeks, started with carbon-ion radiotherapy for a maximal period of 1 year. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy
- Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT
- Patients with neck lymphadenopathy should receive neck dissection before randomization
- With measurable lesion on contrast MR scan
- Age ≥ 18 and < 70 years of age
Key exclusion criteria (15 listed)
- Presence of distant metastasis
- Previously received radioactive particle implantation
- Prior malignancy within 5 years before randomization, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer
- Patients who received local (such as surgery and cryotherapy) or systemic treatment, except for induction chemotherapy after diagnosis of recurrence
- With uncontrolled active infection
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 |
|---|---|---|
| Induction chemotherapyInduction chemotherapy with the regimen of gemcitabine plus nedaplatin. | Drug | Arm-C, Arm-CC |
| Carbon-ion radiotherapyAccelerated carbon-ion beam with pencil beam scanning technique. | Radiation | Arm-C, Arm-CC |
| CamrelizumabAlso: SHR-1210An anti-PD-1 antibody. | Drug | Arm-CC |
Primary outcome
Progression-free survival
Time frame: 2-year
Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.
5 secondary outcomes
Overall survival
Time frame: 2-year
Local progression-free survival
Time frame: 2-year
Regional progression-free survival
Time frame: 2-year
Distant metastasis-free survival
Time frame: 2-year
Number of participants with adverse events
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 38205914Hu J, Huang Q, Hu W, Gao J, Yang J, Zhang H, Lu JJ, Kong L. A protocol for a randomized trial evaluating the role of carbon-ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma. Cancer Med. 2024 Feb;13(3):e6742. doi: 10.1002/cam4.6742. Epub 2024 Jan 11.
- Individual participant dataSharing planned: Yes. Data on participants' clinical features, treatment modalities, survivals and toxicity profile will be shared upon reasonable request. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.
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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.
Jiade J Lu, MD principal investigator
Shanghai Proton and Heavy Ion Center
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 Induction chemotherapy, Carbon-ion radiotherapy and Camrelizumab in people with Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center 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 10 inclusion and 15 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 29 Apr 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 Jiyi Hu, MD, PhD (+8602138296666 ext. 53513, jiyi.hu@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2-year). 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 NCT04143984, 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 29 Apr 2022.