Head and Neck NeoplasmsPhase 2NCT04405154
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
A Phase 2 study testing Camrelizumab, Cisplatin and IMRT or VMAT in people with Head and Neck Neoplasms, run by West China Hospital.
Trial summary
The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Camrelizumab, Cisplatin and IMRT or VMAT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma
- Has unresectable disease and is eligible for definitive chemoradiation based on investigator decision
- Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on RECIST version 1.1
- Has adequate organ function as defined
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
- Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
Who cannot join
- Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
- Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
- Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
- Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or radiotherapy
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or has previously participated in clinical studies with camrelizumab
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- Has received a live vaccine within 30 days prior to the first dose of study therapy
- Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
- Has not recovered from major surgery prior to starting study therapy
- Has known active Hepatitis B or C
- Has known history of Human Immunodeficiency Virus (HIV)
- Has a significant cardiovascular disease
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment
- Has had previous allogeneic tissue/solid organ transplant
- Has active infection requiring systemic therapy
- Is pregnant or breast feeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma
The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Camrelizumab, Cisplatin, IMRT or VMAT
- Keywords
- Head and Neck, Squamous Cell Carcinoma, Immune Checkpoint Inhibitors, Chemoradiation
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabBiological
Also called SHR-1210
Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.
CisplatinDrug
Also called Platinol
75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.
IMRT or VMATRadiation
66-70 Gy given in 33-35 fractions over 6-7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm | Experimental | Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin. Receives: Biological: Camrelizumab; Drug: Cisplatin; Radiation: IMRT or VMAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
Measured: 6 months
Secondary outcomes (3)
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Measured: Up to 5 years
Disease-free Survival (DFS)
DFS is the time from the date of randomization to the date of first record of disease recurrence or death.
Measured: Up to 5 years
Acute Adverse Events (AEs)
The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, West China Hospital
- Investigators
- Yan Li, MD,PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405154
- Sponsor's protocol ID
- HP18-TCR-XN001
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- 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 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04405154
- Acronym / sponsor ID
- HP18-TCR-XN001
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck, Squamous Cell Carcinoma, Immune Checkpoint Inhibitors, Chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 28 May 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 goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Biological: Camrelizumab, Drug: Cisplatin, Radiation: IMRT or VMATCamrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma
- Has unresectable disease and is eligible for definitive chemoradiation based on investigator decision
- Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on RECIST version 1.1
Key exclusion criteria (16 listed)
- Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
- Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
- Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
- Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or radiotherapy
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses. | Biological | Investigational Arm |
| CisplatinAlso: Platinol75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation. | Drug | Investigational Arm |
| IMRT or VMAT66-70 Gy given in 33-35 fractions over 6-7 weeks. | Radiation | Investigational Arm |
Primary outcome
Objective Response Rate
Time frame: 6 months
The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years
Disease-free Survival (DFS)
Time frame: Up to 5 years
Acute Adverse Events (AEs)
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- 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.
Yan Li, MD,PhD principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Cisplatin and IMRT or VMAT in people with Head and Neck Neoplasms, run by West China Hospital.
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 8 inclusion and 16 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Yan Li, MD, PhD (18980606806, yy1240@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 6 months). 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 28 May 2020.