Head and Neck CancerPhase 2HNNCT05777824
Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
A Phase 2 study testing anti-PD-1 or PD-L1 antibody and postoperative radiaotherapy in people with Head and Neck Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- anti-PD-1 or PD-L1 antibody and postoperative radiaotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- The subjects are not limited by gender, age from 18 to 75 years old;
- Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
- Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
- ECOG score 0-1;
- without distant metastasis;
- received induction chemotherapy plus immunotherapy, followed by surgery
- The expected survival is expected to be no less than 6 months.
- No contraindications to chemotherapy, immunotherapy, and radiotherapy;
Who cannot join
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
- Previously experienced head and neck radiation therapy;
- Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;
- Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Beijin, Beijing Municipality, 51000
Wang Jingbo, 15811166516, ivy2019xu@163.com
Xu Yi, 15811166516, ivy2019xu@163.com
About this study
Official title: Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy
To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.
Read the detailed description
Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
- Conditions
- Head and Neck Cancer
- Being tested
- anti-PD-1 or PD-L1 antibody, postoperative radiaotherapy
- Keywords
- postoperative radiotherapy, induction immunotherapy and chemotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-PD-1 or PD-L1 antibodyCombination product
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
postoperative radiaotherapyRadiation
postoperative radiotherapy (60Gy or 50Gy)
| Study group | Role | What they receive |
|---|---|---|
| low-risk and PCR | No intervention | Observation |
| low-risk and MPR | Experimental | immunotherapy maintenance Receives: Combination Product: anti-PD-1 or PD-L1 antibody |
| low-risk and IPR | Experimental | postoperative radiotherapy (50 Gy) and immunotherapy maintenance Receives: Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy |
| high-risk and PCR | Experimental | postoperative radiotherapy (50 Gy) and immunotherapy maintenance Receives: Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy |
| high-risk and MPR | Experimental | postoperative radiotherapy (60 Gy) and immunotherapy maintenance Receives: Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy |
| high-risk and IPR | Experimental | postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance Receives: Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.
Measured: 2 years
Secondary outcomes (3)
Overall survival
defined as the time from random assignment to death from any cause or censored at the date of last follow-up.
Measured: 2 years
Local-Regional failure survival
defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment.
Measured: 2 years
Toxicity Adverse events
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2027 (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 CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junlin Yi, Doctor, Study chair, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777824
- Sponsor's protocol ID
- 22/523-3725
- Acronym
- HN
- Status last verified
- Feb 2023
- First submitted
- 7 Mar 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy
- ClinicalTrials.gov ID
- NCT05777824
- Acronym / sponsor ID
- HN / 22/523-3725
- Conditions
- Head and Neck Cancer
- Keywords
- postoperative radiotherapy, induction immunotherapy and chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Mar 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.
To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.
Detailed description
Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| low-risk and PCR | No intervention | –Observation |
| low-risk and MPR | Experimental | Combination Product: anti-PD-1 or PD-L1 antibodyimmunotherapy maintenance |
| low-risk and IPR | Experimental | Combination Product: anti-PD-1 or PD-L1 antibody, Radiation: postoperative radiaotherapypostoperative radiotherapy (50 Gy) and immunotherapy maintenance |
| high-risk and PCR | Experimental | Combination Product: anti-PD-1 or PD-L1 antibody, Radiation: postoperative radiaotherapypostoperative radiotherapy (50 Gy) and immunotherapy maintenance |
| high-risk and MPR | Experimental | Combination Product: anti-PD-1 or PD-L1 antibody, Radiation: postoperative radiaotherapypostoperative radiotherapy (60 Gy) and immunotherapy maintenance |
| high-risk and IPR | Experimental | Combination Product: anti-PD-1 or PD-L1 antibody, Radiation: postoperative radiaotherapypostoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subjects are not limited by gender, age from 18 to 75 years old;
- Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
- Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging;
- ECOG score 0-1;
- without distant metastasis;
Key exclusion criteria (6 listed)
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy;
- Previously experienced head and neck radiation therapy;
- Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;
- Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;
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 |
|---|---|---|
| anti-PD-1 or PD-L1 antibodyimmunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy | Combination product | high-risk and IPR, high-risk and MPR, high-risk and PCR, low-risk and IPR, low-risk and MPR |
| postoperative radiaotherapypostoperative radiotherapy (60Gy or 50Gy) | Radiation | high-risk and IPR, high-risk and MPR, high-risk and PCR, low-risk and IPR |
Primary outcome
Disease-free survival
Time frame: 2 years
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.
3 secondary outcomes
Overall survival
Time frame: 2 years
Local-Regional failure survival
Time frame: 2 years
Toxicity Adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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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.
Junlin Yi, Doctor study chair
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
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 anti-PD-1 or PD-L1 antibody and postoperative radiaotherapy in people with Head and Neck Cancer, 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Xu (15811166516, 694818945@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 2 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 11 Oct 2023.