Hypopharyngeal CancerPhase 2NCT04539600
Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer
A Phase 2 study testing Camrelizumab in people with Hypopharyngeal Cancer and Immunotherapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypopharyngeal Cancer, Immunotherapy, Induction Chemotherapy
- What is being tested?
- Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 12 Dec 2022
- 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
- Age: 18-75 years;
- Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
- No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
- At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
- Provide tissues for biomarker analysis;
- ECOG PS 0-1;
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- Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN at diagnosis or after biliary drainage, ALT and AST < 5×ULN, BUN、CREA<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
- Contraception during the study;
- At least 12 weeks of life expectancy;
- Willing to join the study and sign informed consent.
Who cannot join
- Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
- Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
- Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
- Have corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
- Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 1 year；
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- Have severe infections (CTCAE> Grade 2) occurred within 4 weeks before the first use of the study drug;
- Have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
- A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia;
- Active tuberculosis, having antituberculosis therapy at present or within 1 year;
- Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10~4 copies/mL) and hepatitis C;
- Have other uncontrollable comorbidities;
- Knowing a history of psychotropic drug abuse, alcohol or drug abuse;
- Pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Shuang Wu, +862087755766, wush77@mail.sysu.edu.cn
About this study
Official title: Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer
The study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer.
- Conditions
- Hypopharyngeal Cancer, Immunotherapy, Induction Chemotherapy
- Being tested
- Camrelizumab
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer.
| Study group | Role | What they receive |
|---|---|---|
| induction chemotherapy + anti-PD-1 antibody | Experimental | Camrelizumab (200 mg, Q3w, 2 cycles in total) combined with induction chemotherapy (taxane-containing regimen, Q3w, 2 cycles in total) followed by concurrent radiotherapy and chemotherapy. Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival, PFS
Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Measured: 1 year
Secondary outcomes (5)
Objective Response Rate (ORR)
Defined as the portion of patients with a tumor size reduction of a predefined amount for a minimum time period. Tumor response will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
Measured: 1 year
Duration of Response（DoR）
Response duration is measured from the time of initial response until documented tumor progression.
Measured: 1 year
Disease Control Rate (DCR)
Refers to the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).
Measured: 1 year
Overall Survival (OS)
Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Measured: 1 year
Adverse events (AE)
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Nov 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion12 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal CancerStudies 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Wei Peng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539600
- Sponsor's protocol ID
- hypopharyngeal SCC 002
- Status last verified
- Aug 2021
- First submitted
- 1 Sep 2020
- Last updated
- 19 Aug 2021
- 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 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04539600
- Acronym / sponsor ID
- hypopharyngeal SCC 002
- Conditions
- Hypopharyngeal Cancer, Immunotherapy, Induction Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 12 Dec 2022 (estimated)
- First posted
- 7 Sep 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 study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| induction chemotherapy + anti-PD-1 antibody | Experimental | Drug: CamrelizumabCamrelizumab (200 mg, Q3w, 2 cycles in total) combined with induction chemotherapy (taxane-containing regimen, Q3w, 2 cycles in total) followed by concurrent radiotherapy and chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-75 years;
- Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
- No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
- At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
- Provide tissues for biomarker analysis;
Key exclusion criteria (15 listed)
- Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
- Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
- Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
- Have corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
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 |
|---|---|---|
| CamrelizumabCamrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer. | Drug | induction chemotherapy + anti-PD-1 antibody |
Primary outcome
Progression-free Survival, PFS
Time frame: 1 year
Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: 1 year
Duration of Response（DoR）
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Adverse events (AE)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.
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 Hypopharyngeal Cancer and Immunotherapy, 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 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 19 Aug 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 Shuang Wu, doctor (+862087755766, wush77@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival, PFS (time frame: 1 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 19 Aug 2021.