Head and Neck Squamous Cell CarcinomaPhase 2NCT06170697
Advanced First-line Treatment of Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Camrelizumab, Cisplatin and Carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths. A considerable number of patients have simple local recurrence in the short term after operation suggesting that the biological behavior of this kind of tumor is relatively… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Jul 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
- 1.Sign written informed consent before implementing any test related processes;
- 2.Male or female subjects aged from 18 to 70 years old;
- 3.For head and neck squamous cell carcinoma after standard radical resection and neck lymph node dissection, the number of lymph node dissections is unlimited;
- 4.No neoadjuvant therapy was received before operation and no adjuvant therapy was received after operation;
- 5.Local or regional recurrence has been confirmed by at least 2 radiographs and a pathological diagnosis is not required;
- 6.The time of recurrence was less than 6 months from operation;
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- 7.Whole body imaging to rule out distant metastases;
- 8.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
- 9.Adequate haematological, hepatic and renal functions defined by the protocol;
- 10.Estimated life expectancy of more than 1year;
- 11.No history of pD-1 or PD-L1 inhibitor treatment;
- 12.No underlying diseases requiring immunosuppressive therapy;
- 13.PD-L1 status is not required, but PD-L1 IHC detection is recommended;
- 14.Women of reproductive age must undergo a negative urinary pregnancy test within 7 days before starting treatment
Who cannot join
- 1.The primary site is squamous cell carcinoma of the nasopharynx or skin;
- 2.Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)；
- 3.Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
- 4.Previously received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors;
- 5.Prior organ transplantation, including allogeneic stem-cell transplantation(except corneal transplantation)；
- 6.Known history of allergy to the drug components of this regimen;
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- 7.There are multiple factors (e.g. severe renal insufficiency, bone marrow suppression) that influence the chemotherapeutic agent selected by the investigator;
- 8.Before starting treatment, it has not fully recovered from the toxicity and / or complications caused by any intervention;
- 9. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, Active tuberculosis, active hepatitis B (HBV DNA <1000 copy/ml,200 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
- 10.Accination with live or live/attenuated viruses within 4 weeks of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines;
- 11.History of uncontrolled intercurrent illness including hypertension, active infection, diabetes , hereditary bleeding , coagulopathy with a risk of bleedingor, cardiac diseases or symptoms;
- 12.Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia, and severe impaired lung function may interfere with the detection and management of suspected drug-associated pulmonary toxicity;
- 13.Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
- 14.Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100020
Jingbo Wang, PhD, +8618500369703, gldanna@163.com
Jingbo Wang
About this study
Official title: A Single-arm，Single Center，Prospective，Phase II Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy for Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma
Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths. A considerable number of patients have simple local recurrence in the short term after operation suggesting that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. This project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.
Read the detailed description
Head and neck squamous cell carcinoma (HNSCC) refers to the general name of squamous cell carcinoma in head and neck organs except nasopharyngeal carcinoma. The main primary sites include oral cavity, oropharynx, hypopharynx, larynx and cervical esophagus. At present, the incidence rate of head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths, of which squamous cell carcinoma accounts for more than 95%.
In daily clinical work, due to insufficient neck cleaning, slow postoperative incision recovery, long waiting time for treatment, untimely postoperative referral and other reasons, a considerable number of patients have simple local recurrence in the short term after operation (e.g. within 6 months) and before the start of planned adjuvant radiotherapy, so that the purpose of PORT has evolved from initial adjuvant treatment to palliative treatment, It also suggests that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. Based on the current clinical and research status, for HNSCC with local regional recurrence in a short time (< 6 months) after operation, both local regional control and remote control must be considered in treatment。 Therefore, this project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Camrelizumab, Cisplatin, Carboplatin, Lobaplatin, Nedaplatin
- 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
Also called immunotherapy
200mg, iv, d1, q3w
CisplatinDrug
Also called chemotherapy
80-100mg/m2, iv, q3w, 2-3 cycles in total
CarboplatinDrug
Also called chemotherapy
AUC 2, iv, q1w, 5-7 cycles in total
LobaplatinDrug
Also called chemotherapy
30mg/m2, iv, q3w, 2-3 cycles in total
NedaplatinDrug
Also called chemotherapy
25-30 mg/m2, iv, q1w, 5-7 cycles in total
RadiotherapyRadiation
Also called radiation therapy
PGTVp/PGTVnd 66-70Gy/2-2.2Gy/30-35F；PTV1 60Gy/1.8-2.0Gy/30-33F；PTV2 50Gy/1.8-20Gy/25-28F；Start 1-2 weeks after the start of immunotherapy, 1 time before the start of simultaneous chemotherapy, up to 3 times during the concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy | Experimental | patients with short-term postoperative progression receive camrelizumab and platin-based chemotherapy concurrent with radiotherapy. Receives: Drug: Camrelizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Lobaplatin; Drug: Nedaplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Progression-free survival (1y-PFS)
Proportion of patients with disease-free survival at 3 years after randomization
Measured: up to 1 years
Secondary outcomes (5)
Objective Response Rate（ORR）
Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Measured: From the start of randomization to a minimum of 24 months
Disease Control Rate (DCR)
Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated
Measured: From the start of randomization to a minimum of 24 months
Duration of Response (DoR)
DoR is defined as the time from the measurement of the first compliance with Cr or pr (whichever occurs first) to the first true recording of disease recurrence or progression.
Measured: From the start of randomization to a minimum of 48 months
Overall survival (OS)
OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.
Measured: From the start of randomization to a minimum of 48 months
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Mar 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingbo Wang, Principal investigator, Chinese academy of medical science, cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170697
- Sponsor's protocol ID
- 22-OBU-BJ-HNC-II-008
- Status last verified
- Jul 2023
- First submitted
- 6 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be avaliable upon request to PI
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm，Single Center，Prospective，Phase II Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy for Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06170697
- Acronym / sponsor ID
- 22-OBU-BJ-HNC-II-008
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 Dec 2023 (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.
Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths. A considerable number of patients have simple local recurrence in the short term after operation suggesting that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. This project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.
Detailed description
Head and neck squamous cell carcinoma (HNSCC) refers to the general name of squamous cell carcinoma in head and neck organs except nasopharyngeal carcinoma. The main primary sites include oral cavity, oropharynx, hypopharynx, larynx and cervical esophagus. At present, the incidence rate of head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths, of which squamous cell carcinoma accounts for more than 95%.
In daily clinical work, due to insufficient neck cleaning, slow postoperative incision recovery, long waiting time for treatment, untimely postoperative referral and other reasons, a considerable number of patients have simple local recurrence in the short term after operation (e.g. within 6 months) and before the start of planned adjuvant radiotherapy, so that the purpose of PORT has evolved from initial adjuvant treatment to palliative treatment, It also suggests that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. Based on the current clinical and research status, for HNSCC with local regional recurrence in a short time (< 6 months) after operation, both local regional control and remote control must be considered in treatment。 Therefore, this project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy | Experimental | Drug: Camrelizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Lobaplatin, Drug: Nedaplatin, Radiation: Radiotherapypatients with short-term postoperative progression receive camrelizumab and platin-based chemotherapy concurrent with radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1.Sign written informed consent before implementing any test related processes;
- 2.Male or female subjects aged from 18 to 70 years old;
- 3.For head and neck squamous cell carcinoma after standard radical resection and neck lymph node dissection, the number of lymph node dissections is unlimited;
- 4.No neoadjuvant therapy was received before operation and no adjuvant therapy was received after operation;
- 5.Local or regional recurrence has been confirmed by at least 2 radiographs and a pathological diagnosis is not required;
Key exclusion criteria (14 listed)
- 1.The primary site is squamous cell carcinoma of the nasopharynx or skin;
- 2.Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)；
- 3.Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
- 4.Previously received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors;
- 5.Prior organ transplantation, including allogeneic stem-cell transplantation(except corneal transplantation)；
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: immunotherapy200mg, iv, d1, q3w | Drug | Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy |
| CisplatinAlso: chemotherapy80-100mg/m2, iv, q3w, 2-3 cycles in total | Drug | Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy |
| CarboplatinAlso: chemotherapyAUC 2, iv, q1w, 5-7 cycles in total | Drug | Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy |
| LobaplatinAlso: chemotherapy30mg/m2, iv, q3w, 2-3 cycles in total | Drug | Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy |
| NedaplatinAlso: chemotherapy25-30 mg/m2, iv, q1w, 5-7 cycles in total | Drug | Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy |
| RadiotherapyAlso: radiation therapyPGTVp/PGTVnd 66-70Gy/2-2.2Gy/30-35F；PTV1 60Gy/1.8-2.0Gy/30-33F；PTV2 50Gy/1.8-20Gy/25-28F；Start 1-2 weeks after the start of immunotherapy, 1 time before the start of simultaneous chemotherapy, up to 3 times during the concurrent chemoradiotherapy | Radiation | Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy |
Primary outcome
1 year Progression-free survival (1y-PFS)
Time frame: up to 1 years
Proportion of patients with disease-free survival at 3 years after randomization
5 secondary outcomes
Objective Response Rate（ORR）
Time frame: From the start of randomization to a minimum of 24 months
Disease Control Rate (DCR)
Time frame: From the start of randomization to a minimum of 24 months
Duration of Response (DoR)
Time frame: From the start of randomization to a minimum of 48 months
Overall survival (OS)
Time frame: From the start of randomization to a minimum of 48 months
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No. IPD will be avaliable upon request to PI
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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.
Jingbo Wang principal investigator
Chinese academy of medical science, cancer hospital
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, Cisplatin and Carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, 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 14 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 20 Dec 2023. 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 Jingbo Wang (+8618500369703, wangjingbo201001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Progression-free survival (1y-PFS) (time frame: up to 1 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 20 Dec 2023.