HNSCCPhase 2NCT04861467
Camrelizumab as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Camrelizumab in people with HNSCC, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HNSCC
- What is being tested?
- Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 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
- Who have histologic or cytologic confirmation of head and neck squamous cell carcinoma in the mouth, oropharynx (p16-), hypopharynx, or larynx.
- Local advanced head and neck squamous cell carcinoma diagnosed as stage III-IVa by AJCC 8
- Except for the prescribed radical radiotherapy and chemotherapy regimen, there has been no previous treatment for LA-HNSCC systemic antitumor or local radical therapy (allowing the prescribed induction chemotherapy regimen before radical radiotherapy and chemotherapy)
- 28 days after radical radiotherapy and chemotherapy (radiotherapy and chemotherapy (±7 days) did not show disease progression, and consideration was given within 28 days after curative effect evaluation
- Clinically assessable lesions according to RECIST1.1,(lesion length ≥10 mm or lymph node short diameter ≥15 mm)
- The age at which informed consent is signed is 18-70 years, male and female
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- KPS score ≥80 percent
- Estimated lifetime ≥6 months
- The function of important organs meets the following requirements (excluding the use of any blood components and cytokines within 14 days):
- Normal bone marrow reserve function: WBC≥3.0×10^9/ L, NEUT≥1.5×10^9/ L, PLT≥80×10^9/ L, Hb≥90g/L Normal renal function or SCr≤1.5 times normal upper limit (ULN) or Ccr≥50 ml/min ; Normal liver function or TBIL≤1.5 times the upper limit of normal value (ULN); AST or ALT level 2.5 times the upper limit of normal value (ULN);
- Ability and willingness to follow research and follow-up procedures
- Men and women of childbearing age must agree to adequate contraception throughout the study period and within 6 months after treatment
- The subjects volunteered to join the clinical study and signed informed consent, good compliance and follow-up
Who cannot join
- 1.Have received any systemic anti-tumor therapy against the target lesion
- Previous experience in head and neck radiotherapy
- Previous immunotherapies including anti PD-1/PD-L1, anti CTLA-4, etc
- Subjects who received anti-tumor vaccines or other immunomodulatory drugs (e.g. interleukin-2, thymosin, Lentinus edodes polysaccharide, etc.) within 1 month prior to joining the group, or who received live attenuated vaccines
- Subjects who had been systematically treated with corticosteroids (prednisone or other equivalent hormones >10 mg/ days) or other immunosuppressants within 1 month of entry. To allow inhaled or local use of corticosteroids in the absence of active autoimmune disease, as well as adrenocorticotropic replacement therapy ≤10 days mg/ dose of prednisone
- Pleural effusions, pericardial effusions or ascites requiring drainage, or serosal effusions for treatment within 2 weeks prior to group entry
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- No active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary, vasculitis, nephritis, hyperthyroidism, hypothyroidism) may be included
- Subjects with severe infection within 1 month prior to admission, including, but not limited to, infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection, or unexplained fever >38.5℃ during screening, prior to first administration
- Severe cardiovascular disease: grade II myocardial ischemia or myocardial infarction, uncontrolled arrhythmia; grade III ~ IV cardiac insufficiency, or echocardiography indicated that left ventricular ejection fraction (LVEF)<50%;
- The subjects were treated with bronchiectasis and other systemic treatments. Asthma control was unsatisfactory and could not be included (asthma was completely alleviated in childhood and included without any intervention in adults)
- HIV infection or known AIDS, active hepatitis B (HBV DNA≥500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
- Subjects with a history of other malignancies within five years (except complete treatment of skin cancer with cervical or basal cell carcinoma or squamous cell carcinoma in situ)
- Patients with a clear history of allergies may be allergic to, or intolerant to Camrelizumab
- Persons with a history of substance abuse and who are unable to abstain or who have mental disorders Increasing the risk associated with participating in a study or research drug and, according to the researcher's judgment, other circumstances in which the subjects are not suitable for inclusion in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital, Chineses Academy of Medical Sciences
Beijing, 100021
Junlin Yi, M.D., 13661217998, yijunlin1969@163.com
Junlin Yi, M.D.
About this study
Official title: A Randomized, Open Study of Camrelizumab vs Placebo as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.
- Conditions
- HNSCC
- Being tested
- Camrelizumab
- Keywords
- Immunotherapy, Chemoradiation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Camrelizumab | Experimental | camrelizumab as maintenance therapy after Chemoradiation(evaluation results：PR/SD) Receives: Drug: Camrelizumab |
| observation | No intervention | observation after Chemoradiation |
| Exploration：Camrelizumab | Experimental | camrelizumab for maintenance after chemoradiation( evaluation results：CR) Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
median progression-free survival(in accordance with RECIST1.1)
mPFS is the median time from the date of randomization to the date of first record of disease progression or death.
Measured: Up to 3 years
Secondary outcomes (6)
1 year progression-free survival rate
Measured: 1 year from the the date of randomization
overall survival
OS is the time from randomization to death due to any cause.
Measured: Up to 3 years
objective response rate
Measured: Up to 3 years
disease control rate
Measured: Up to 3 years
time to progression
Measured: Up to 3 years
progression-free survival(in accordance with irRECIST1.1)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies 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
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Lin Yi, MD, Chinese Academy of Medical Sciences
- Investigators
- Junlin Yi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861467
- Sponsor's protocol ID
- CATCH
- Status last verified
- Mar 2021
- First submitted
- 22 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Study of Camrelizumab vs Placebo as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04861467
- Acronym / sponsor ID
- CATCH
- Conditions
- HNSCC
- Keywords
- Immunotherapy, Chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Apr 2021 (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 study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Camrelizumab | Experimental | Drug: Camrelizumabcamrelizumab as maintenance therapy after Chemoradiation(evaluation results：PR/SD) |
| observation | No intervention | –observation after Chemoradiation |
| Exploration：Camrelizumab | Experimental | Drug: Camrelizumabcamrelizumab for maintenance after chemoradiation( evaluation results：CR) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Who have histologic or cytologic confirmation of head and neck squamous cell carcinoma in the mouth, oropharynx (p16-), hypopharynx, or larynx.
- Local advanced head and neck squamous cell carcinoma diagnosed as stage III-IVa by AJCC 8
- Except for the prescribed radical radiotherapy and chemotherapy regimen, there has been no previous treatment for LA-HNSCC systemic antitumor or local radical therapy (allowing the prescribed induction chemotherapy regimen before radical radiotherapy and chemotherapy)
- 28 days after radical radiotherapy and chemotherapy (radiotherapy and chemotherapy (±7 days) did not show disease progression, and consideration was given within 28 days after curative effect evaluation
- Clinically assessable lesions according to RECIST1.1,(lesion length ≥10 mm or lymph node short diameter ≥15 mm)
Key exclusion criteria (14 listed)
- 1.Have received any systemic anti-tumor therapy against the target lesion
- Previous experience in head and neck radiotherapy
- Previous immunotherapies including anti PD-1/PD-L1, anti CTLA-4, etc
- Subjects who received anti-tumor vaccines or other immunomodulatory drugs (e.g. interleukin-2, thymosin, Lentinus edodes polysaccharide, etc.) within 1 month prior to joining the group, or who received live attenuated vaccines
- Subjects who had been systematically treated with corticosteroids (prednisone or other equivalent hormones >10 mg/ days) or other immunosuppressants within 1 month of entry. To allow inhaled or local use of corticosteroids in the absence of active autoimmune disease, as well as adrenocorticotropic replacement therapy ≤10 days mg/ dose of prednisone
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 |
|---|---|---|
| CamrelizumabIV | Drug | Experimental: Camrelizumab, Exploration：Camrelizumab |
Primary outcome
median progression-free survival(in accordance with RECIST1.1)
Time frame: Up to 3 years
mPFS is the median time from the date of randomization to the date of first record of disease progression or death.
6 secondary outcomes
1 year progression-free survival rate
Time frame: 1 year from the the date of randomization
overall survival
Time frame: Up to 3 years
objective response rate
Time frame: Up to 3 years
disease control rate
Time frame: Up to 3 years
time to progression
Time frame: Up to 3 years
progression-free survival(in accordance with irRECIST1.1)
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- 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.
Junlin Yi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Camrelizumab in people with HNSCC, run by Chinese Academy of Medical Sciences 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 13 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. 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 Junlin Yi (13661217998, yijunlin1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median progression-free survival(in accordance with RECIST1.1) (time frame: Up to 3 years). 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 27 Apr 2021.