Head and Neck CancerPhase 2NCT06345287
Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC
A Phase 2 study testing radical radiotherapy (60Gy), radical radiotherapy (66Gy) and radical radiotherapy (70Gy) 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
The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. 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?
- radical radiotherapy (60Gy), radical radiotherapy (66Gy) and radical radiotherapy (70Gy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- 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
- Head and neck squamous cell carcinoma patients who undergo 2-4 cycles of induction chemotherapy and immunotherapy and plan to undergo radical radiotherapy treatment ( after MDT evaluation and communication with the patient, surgery is not recommended to preserve organ function, or the patient refuses surgery );
- Age range from 18 to 75 years old;
- Squamous cell carcinoma of the head and neck confirmed by pathological tissue biopsy;
- Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition);
- HPV or P16 (-);
- ECOG score 0-1 points;
Show all 10Show fewer
- No contraindications to immunotherapy and radiotherapy;
- The functional level of the main organs meets the following standards:1) The blood routine examination standards need to meet: WBC ≥ 3.0 × 109/L, ANC ≥ 2.0 × 109/L, PLT ≥ 100 × 109/L, HGB ≥ 90g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors correction);2) Biochemical examination must meet the following standards: TBIL ≤ 2.0 × ULN, ALT, AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN, or endogenous creatinine clearance rate ≥ 60ml/min (Cockcroft Gout formula);3) Good coagulation function: defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulant treatment, as long as the PT is within the intended range of use of the anticoagulant drug;4) The myocardial enzyme spectrum is within the normal range;
- Women of childbearing age must have taken reliable contraceptive measures, or have undergone pregnancy tests (serum or urine) within 7 days before enrollment, and the results are negative. They must be willing to use effective methods of contraception during the treatment period and within 2 months thereafter. For male participants whose partners are women of childbearing age, effective methods of contraception should be used during and within 2 months after treatment;
- Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Previous or concurrent incurable malignant tumors in other parts, except cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma and superficial bladder cancer;
- Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); Asthma patients who suffer from vitiligo or have completely relieved childhood asthma and do not require any intervention in adulthood can be included, while asthma patients who require medical intervention with bronchodilators cannot be included;
- Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)<50% indicated by echocardiography; Have experienced myocardial infarction within one year;
- Active infection or unexplained fever exceeding 38.5 ℃ during screening or before first administration (according to the researcher's judgment, subjects with fever caused by tumors can be included in the study);
- People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method);
- Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1;
Show all 10Show fewer
- Known to be allergic to cisplatin, macromolecular protein preparations, or any anti PD-1 antibody component;
- If the subject undergoes major surgery without tumor treatment, the toxic reactions and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
- Pregnant or lactating women;
- In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.
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
Beijing
Jingbo Wang, Doctor, 15811166516, wangjingbo303@yahoo.com
About this study
Official title: Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related Head and Neck Squamous Cell Carcinoma
The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
Read the detailed description
Induction chemotherapy combined with immunotherapy has shown promising efficacy in locally advanced head and neck cancers. However, the appropriate dose and range of the following radical radiotherapy treatment remains unknown. Eligibility patients were assigned to three arms depending on the degree of clinical remission: clinical complete response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy + immunotherapy maintenance). Progression-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
- Conditions
- Head and Neck Cancer
- Being tested
- radical radiotherapy (60Gy), radical radiotherapy (66Gy), radical radiotherapy (70Gy), anti-PD-1 or PD-L1 antibody
- Keywords
- radical 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.
radical radiotherapy (60Gy)Radiation
concurrent chemoradiotherapy (60Gy) after induction therapy
radical radiotherapy (66Gy)Radiation
concurrent chemoradiotherapy (66Gy) after induction therapy
radical radiotherapy (70Gy)Radiation
concurrent chemoradiotherapy (70Gy) after induction therapy
anti-PD-1 or PD-L1 antibodyCombination product
immunotherapy maintenance with anti-PD-1 or PDL1antibody every three weeks for 1 year after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| clinical complete response | Experimental | radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance Receives: Radiation: radical radiotherapy (60Gy); Combination Product: anti-PD-1 or PD-L1 antibody |
| deep partial response | Experimental | radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance Receives: Radiation: radical radiotherapy (66Gy); Combination Product: anti-PD-1 or PD-L1 antibody |
| non-deep partial response | Experimental | radiotherapy 70Gy+ concurrent chemotherapy + immunotherapy maintenance Receives: Radiation: radical radiotherapy (70Gy); Combination Product: anti-PD-1 or PD-L1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-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 (4)
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
Deep partial response
Defined as maximum tumor diameter retreat ≥ 50%
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 posted3 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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
- 133 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
- NCT06345287
- Sponsor's protocol ID
- 24/018-4298
- Status last verified
- Jan 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06345287
- Acronym / sponsor ID
- 24/018-4298
- Conditions
- Head and Neck Cancer
- Keywords
- radical radiotherapy, induction immunotherapy and chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2024 (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 aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
Detailed description
Induction chemotherapy combined with immunotherapy has shown promising efficacy in locally advanced head and neck cancers. However, the appropriate dose and range of the following radical radiotherapy treatment remains unknown. Eligibility patients were assigned to three arms depending on the degree of clinical remission: clinical complete response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy + immunotherapy maintenance). Progression-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
- 3
| Arm | Type | Receives |
|---|---|---|
| clinical complete response | Experimental | Radiation: radical radiotherapy (60Gy), Combination Product: anti-PD-1 or PD-L1 antibodyradiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance |
| deep partial response | Experimental | Radiation: radical radiotherapy (66Gy), Combination Product: anti-PD-1 or PD-L1 antibodyradiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance |
| non-deep partial response | Experimental | Radiation: radical radiotherapy (70Gy), Combination Product: anti-PD-1 or PD-L1 antibodyradiotherapy 70Gy+ concurrent chemotherapy + immunotherapy maintenance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Head and neck squamous cell carcinoma patients who undergo 2-4 cycles of induction chemotherapy and immunotherapy and plan to undergo radical radiotherapy treatment ( after MDT evaluation and communication with the patient, surgery is not recommended to preserve organ function, or the patient refuses surgery );
- Age range from 18 to 75 years old;
- Squamous cell carcinoma of the head and neck confirmed by pathological tissue biopsy;
- Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition);
- HPV or P16 (-);
Key exclusion criteria (10 listed)
- Previous or concurrent incurable malignant tumors in other parts, except cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma and superficial bladder cancer;
- Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); Asthma patients who suffer from vitiligo or have completely relieved childhood asthma and do not require any intervention in adulthood can be included, while asthma patients who require medical intervention with bronchodilators cannot be included;
- Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)<50% indicated by echocardiography; Have experienced myocardial infarction within one year;
- Active infection or unexplained fever exceeding 38.5 ℃ during screening or before first administration (according to the researcher's judgment, subjects with fever caused by tumors can be included in the study);
- People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method);
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 |
|---|---|---|
| radical radiotherapy (60Gy)concurrent chemoradiotherapy (60Gy) after induction therapy | Radiation | clinical complete response |
| radical radiotherapy (66Gy)concurrent chemoradiotherapy (66Gy) after induction therapy | Radiation | deep partial response |
| radical radiotherapy (70Gy)concurrent chemoradiotherapy (70Gy) after induction therapy | Radiation | non-deep partial response |
| anti-PD-1 or PD-L1 antibodyimmunotherapy maintenance with anti-PD-1 or PDL1antibody every three weeks for 1 year after radiotherapy | Combination product | clinical complete response, deep partial response, non-deep partial response |
Primary outcome
Progression-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
4 secondary outcomes
Overall survival
Time frame: 2 years
Deep partial response
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 3 Apr 2024.
Related trials for Head and Neck Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Head and Neck Cancer
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
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 radical radiotherapy (60Gy), radical radiotherapy (66Gy) and radical radiotherapy (70Gy) 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 10 inclusion and 10 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 3 Apr 2024. 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 Yang Meng (13359595417, YangMeng@pumc.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 (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 3 Apr 2024.