Head and Neck Squamous Cell CarcinomaPhase 2iCSDeRNCT05476965
Selected De-escalation Radiotherapy for Postoperative Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing induction therapy; surgery; radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Radiotherapy, run by Hubei Cancer Hospital at 1 site in China.
Trial summary
This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Radiotherapy, Immunotherapy
- What is being tested?
- induction therapy; surgery; radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the age of 18 to 65.
- Newly diagnosed pathologically confirmed locally advanced head and neck squamous cell carcinoma, including oral cancer, oropharyngeal cancer, laryngeal cancer, while nasopharyngeal carcinoma was excluded. The P16 status of oropharyngeal carcinoma is known.
- Locally advanced resectable head and neck tumors (stage III and stage IV) were enrolled and radiotherapy is expected to be performed within 4 or 6 weeks after surgery. Tumor staging is based on AJCC/UICC 8th Edition. All the patients must undergo the following examinations to determine the tomor stage before the treatment: complete medical history, physical examination, blood and biochemical routine, head and neck CT or MRI, chest CT scan, abdominal ultrasound and bone scan. In addition, 18F PET/CT can be used to replace the last three imaging examinations mentioned above.
- ECOG performance status 0 or 1.
- Normal Organ function
- Leukocytes ≥ 4×109/L
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- Hemoglobin ≥ 90 g/L
- Platelets ≥ 100×109/L
- Total bilirubin ≤ 1.5x upper limit of normal
- Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) ≤ 2.5x upper limit of normal
- Alkaline phosphatase ≤ 2.5x upper limit of normal
- Creatinine clearance > 60 mL/min
- Normal thyroid function, amylase, pituitary function, inflammation and infection index, myocardial enzyme, and ECG. For patients with abnormal ECG or cardiovascular history but not meet the exclusion criteria, a cardiac color ultrasound is needed, and the results should be normal.
- Patients must sign an informed consent form prior to study entry and they must be willing to comply with the visit, treatment protocol, laboratory examination and other requirements included in the study protocol.
- Women of childbearing potential and men with fertility partners must agree to follow instructions for methods of contraception (such as condoms or contraceptive drugs) from screening to 1 years after completing treatment.
Who cannot join
- Positive HBsAg and HBV DNA > 1×103 copies/ml, or anti-HCV antibody positive.
- Positive anti-HIV antibody or diagnosed as AIDS.
- patients with active tuberculosis history (whether treated or not) in the past 1 years, or with a history of tuberculosis more than 1 years (except those who had received regular anti-tuberculosis treatment).
- Has active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) are not included.
- Diagnosis of interstitial pneumonia or pneumonia and receiving oral or intravenous steroid therapy in the past 1 year.
- Receiving systemic glucocorticoid (10 mg prednisone per day) therapy or any other form of immunosuppressive therapy (excluding inhaled or topical corticosteroids).
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- Uncontrolled heart disease, such as: heart failure, NYHA level ≥ 2; instability Angina pectoris; myocardial infarction history in the past 1 year; supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
- Pregnant or breastfeeding female patients (women of childbearing potential must have urine pregnancy test).
- Suffering from other malignant tumors at previously or currently. Additionally, well treated non melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer are not included.
- Allergic to macromolecular protein or any component of anti-PD1 antibody.
- Active infection requiring systemic therapy no more than one week.
- Has received a live vaccine within 30 days before administrating anti-PD-1 antibody.
- organ transplantation history.
- Other situations assessed by the investigator that may endanger patient safety or compliance, such as serious diseases requiring treatment (including mental diseases), serious abnormal test results, or with other family or social high-risk factor.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430000
Yuan Wu, Dr., 862787670318, 344351420@qq.com
About this study
Official title: A Phase II Trial of Cisplatinum, Paclitaxel, and Sintilimab Induction Therapy Followed by De-escalation Radiotherapy for Patients With Postoperative Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used.
- Being tested
- induction therapy; surgery; radiotherapy
- 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.
induction therapy; surgery; radiotherapyCombination product
Radiotherapy: de-escalation radiotherapy or standard radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | De-escalation radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: De-escalation radiotherapy Receives: Combination Product: induction therapy; surgery; radiotherapy |
| Arm 2 | Active comparator | Arm 2 Standard radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: Standard radiotherapy Receives: Combination Product: induction therapy; surgery; radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The objective is to intensify induction chemotherapy with the addition of anti-PD-1 McAb sintilimab aimed at acquiring a higher postoperative pCR.
Measured: 3 weeks
Secondary outcomes (4)
Radiation dose of normal organs and treatment-related adverse events
Assess the radiation dose of normal organs between the de-escalation radiotherapy group or standard radiotherapy group. Furthermore, toxicities reaction between two groups also been compared. Adverse events were any untoward medical occurrence in a participant who received study interventions without regard to possibility of causal relationship.
Measured: 12 months
Safety of sintilimab in combination with chemotherapy
Evaluate the safety of sintilimab in combination with chemotherapy followed by surgery and radiotherapy in advanced head and neck squamous cell carcinoma patients.
Measured: 12 months
Functional assessment of cancer therapy scale head and neck quality of life assessments
Evaluate quality of life in all patients. The specific modules H\&N35 in Quality of Life Questionnaire Core 30 module (QLQ-C30) and European Organization for Research and Treatment of Cancer (EORTC) and Functional Assessment of Cancer Therapy (FACT) H\&N V4.0 were used. Both of them are standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.
Measured: 6 months after the use of anti-PD-1 McAb sintilimab
Progression free survival (PFS) in 2 years
PFS was defined as the time from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Comparing the PFS at 24 months after completing chemotherapy, surgery, and radiotherapy between arm 1 and arm 2.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2024 (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 Head and Neck Squamous Cell 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Qian, Hubei Cancer Hospital
- Investigators
- Desheng Hu, Dr., Study chair, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476965
- Sponsor's protocol ID
- HN010815
- Acronym
- iCSDeR
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qian Y, Hu L, Jiang L, Wang M, Jin X, Deng W, Wu K, Qin S, Hu D, Chen J, Wu Y. Response-Adapted Postoperative Therapy Following Neoadjuvant Chemoimmunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: a phase II trial. Nat Commun. 2026 Sep 28;17(1):11193. doi: 10.1038/s41467-026-77698-4.
PubMed 42946703
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cisplatinum, Paclitaxel, and Sintilimab Induction Therapy Followed by De-escalation Radiotherapy for Patients With Postoperative Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05476965
- Acronym / sponsor ID
- iCSDeR / HN010815
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Jul 2022 (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.
This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Combination Product: induction therapy; surgery; radiotherapyDe-escalation radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: De-escalation radiotherapy |
| Arm 2 | Active comparator | Combination Product: induction therapy; surgery; radiotherapyArm 2 Standard radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: Standard radiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Between the age of 18 to 65.
- Newly diagnosed pathologically confirmed locally advanced head and neck squamous cell carcinoma, including oral cancer, oropharyngeal cancer, laryngeal cancer, while nasopharyngeal carcinoma was excluded. The P16 status of oropharyngeal carcinoma is known.
- Locally advanced resectable head and neck tumors (stage III and stage IV) were enrolled and radiotherapy is expected to be performed within 4 or 6 weeks after surgery. Tumor staging is based on AJCC/UICC 8th Edition. All the patients must undergo the following examinations to determine the tomor stage before the treatment: complete medical history, physical examination, blood and biochemical routine, head and neck CT or MRI, chest CT scan, abdominal ultrasound and bone scan. In addition, 18F PET/CT can be used to replace the last three imaging examinations mentioned above.
- ECOG performance status 0 or 1.
- Normal Organ function
Key exclusion criteria (14 listed)
- Positive HBsAg and HBV DNA > 1×103 copies/ml, or anti-HCV antibody positive.
- Positive anti-HIV antibody or diagnosed as AIDS.
- patients with active tuberculosis history (whether treated or not) in the past 1 years, or with a history of tuberculosis more than 1 years (except those who had received regular anti-tuberculosis treatment).
- Has active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) are not included.
- Diagnosis of interstitial pneumonia or pneumonia and receiving oral or intravenous steroid therapy in the past 1 year.
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 therapy; surgery; radiotherapyRadiotherapy: de-escalation radiotherapy or standard radiotherapy | Combination product | Arm 1, Arm 2 |
Primary outcome
Pathological complete response rate (pCR)
Time frame: 3 weeks
pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The objective is to intensify induction chemotherapy with the addition of anti-PD-1 McAb sintilimab aimed at acquiring a higher postoperative pCR.
4 secondary outcomes
Radiation dose of normal organs and treatment-related adverse events
Time frame: 12 months
Safety of sintilimab in combination with chemotherapy
Time frame: 12 months
Functional assessment of cancer therapy scale head and neck quality of life assessments
Time frame: 6 months after the use of anti-PD-1 McAb sintilimab
Progression free survival (PFS) in 2 years
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 42946703Qian Y, Hu L, Jiang L, Wang M, Jin X, Deng W, Wu K, Qin S, Hu D, Chen J, Wu Y. Response-Adapted Postoperative Therapy Following Neoadjuvant Chemoimmunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: a phase II trial. Nat Commun. 2026 Sep 28;17(1):11193. doi: 10.1038/s41467-026-77698-4.
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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.
Desheng Hu, Dr. study chair
Hubei 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 induction therapy; surgery; radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Radiotherapy, run by Hubei Cancer Hospital 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 15 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 Jul 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 Yuan Wu, Dr. (862787670318, 344351420@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: 3 weeks). 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 NCT05476965, 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 27 Jul 2022.