Head and Neck Squamous Cell CarcinomaPhase 2RAIN-HNSCCNCT07554768
Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC
A Phase 2 study testing Adebrelimab and radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Chen Chunyan at 1 site in China.
Trial summary
The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. 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, Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Adebrelimab and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC).
- Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer.
- PD-L1 expression with a Combined Positive Score (CPS) ≥ 1.
- Karnofsky Performance Status (KPS) score ≥ 70.
- Age between 18 and 70 years (inclusive).
- Evaluated by a multidisciplinary team (MDT) as resectable or borderline resectable, and suitable for preoperative Stereotactic Body Radiotherapy (SBRT).
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- Adequate organ function within 7 days prior to enrollment, meeting laboratory criteria for hematology, liver, and renal function.
- Anatomical requirements for SBRT: Lesions must be localized with adequate anatomical space for high-precision radiotherapy without exceeding safety limits for Organs at Risk (OARs).
- Voluntary participation with a signed Informed Consent Form (ICF).
Who cannot join
- Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies.
- Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections.
- Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU/mL).
- Pregnant or breastfeeding women.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Chunyan Chen, MD, +86-13826423812, chenchuny@sysucc.org.cn
About this study
Official title: A Randomized, Controlled, Phase II Clinical Study of Neoadjuvant Radio-immunotherapy Versus Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).
Read the detailed description
This is a randomized, controlled, open-label, Phase II clinical trial designed to compare the efficacy and safety of neoadjuvant radiotherapy combined with Adebrelimab versus Adebrelimab monotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Experimental Arm (Radio-immunotherapy): Patients will receive neoadjuvant radiotherapy (SBRT 24 Gy in 3 fractions) followed by or concurrent with 2 cycles of Adebrelimab (1200mg, Q3W).
Control Arm (Immunotherapy alone): Patients will receive 2 cycles of Adebrelimab (1200mg, Q3W) as monotherapy.
Following the completion of neoadjuvant therapy, a multidisciplinary team (MDT) will evaluate the patients' response. Eligible patients will then undergo standard surgical resection of the primary tumor and neck dissection within 3 to 4 weeks after the last dose of immunotherapy.
The primary endpoint is the Major Pathological Response (MPR) rate, defined as less than or equal to 10% residual viable tumor in the resected specimen. Secondary endpoints include Pathological Complete Response (pCR) rate, Objective Response Rate (ORR) according to RECIST 1.1, Event-Free Survival (EFS), and the incidence of treatment-emergent adverse events (TEAEs) graded by CTCAE 5.0.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
- Being tested
- Adebrelimab, radiotherapy
- Keywords
- Neoadjuvant Therapy, Radio-immunotherapy, Adebrelimab, PD-L1 Inhibitor, SBRT
- 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.
AdebrelimabDrug
A humanized IgG4 monoclonal antibody against programmed cell death-ligand 1 (PD-L1). Dosage: 1200 mg administered via intravenous (IV) infusion on Day 1 of each 21-day cycle, for a total of 2 cycles in the neoadjuvant setting.
radiotherapyRadiation
Neoadjuvant radiotherapy targeting the primary tumor and involved cervical lymph nodes. (SBRT with a total dose of [24] Gy in [3] fractions).
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Radio-immunotherapy (Adebrelimab + RT) | Experimental | Patients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) combined with radiotherapy (SBRT), followed by surgical resection. Receives: Drug: Adebrelimab; Radiation: radiotherapy |
| Neoadjuvant Immunotherapy Monotherapy (Adebrelimab) | Active comparator | Patients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) monotherapy, followed by surgical resection. Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
The percentage of participants with 10% or less residual viable tumor cells in the resected primary tumor and lymph nodes following neoadjuvant therapy. Assessment will be performed by independent pathologists.
Measured: At the time of surgery (approximately 6-8 weeks after the first dose of neoadjuvant therapy).
Secondary outcomes (3)
Pathological Complete Response (pCR) Rate
The percentage of participants with no residual viable tumor cells (0%) in the resected primary tumor and lymph nodes.
Measured: At the time of surgery.
Objective Response Rate (ORR)
The percentage of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria as assessed by imaging (CT or MRI) prior to surgery.
Measured: From the first dose of neoadjuvant therapy until pre-operative clinical evaluation (approximately 6 weeks).
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Percentage of participants with treatment-emergent adverse events (TEAEs) as defined by CTCAE v5.0. Adverse events include immune-related adverse events (irAEs) and radiation-related toxicities. Severity will be graded for each event according to CTCAE v5.0 criteria.
Measured: From the start of treatment up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open-label, two-arm, parallel-assignment Phase II study. Eligible patients with locally advanced HNSCC will be randomized at a 1:1 ratio to receive either neoadjuvant Adebrelimab in combination with radiotherapy (Experimental Arm) or Adebrelimab monotherapy (Control Arm). Randomization will be stratified by \[stratification factors, e.g., clinical stage (III vs. IV) or primary tumor site\]. Both groups will undergo surgical resection following the completion of neoadjuvant therapy.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Chunyan
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Responsible party
- Sponsor-investigator, Chen Chunyan, Sun Yat-sen University
- Investigators
- Chunyan Chen, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554768
- Sponsor's protocol ID
- B2026-158-01
- Acronym
- RAIN-HNSCC
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase II Clinical Study of Neoadjuvant Radio-immunotherapy Versus Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07554768
- Acronym / sponsor ID
- RAIN-HNSCC / B2026-158-01
- Conditions
- Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
- Keywords
- Neoadjuvant Therapy, Radio-immunotherapy, Adebrelimab, PD-L1 Inhibitor, SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chen ChunyanUniversity, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 28 Apr 2026 (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 purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).
Detailed description
This is a randomized, controlled, open-label, Phase II clinical trial designed to compare the efficacy and safety of neoadjuvant radiotherapy combined with Adebrelimab versus Adebrelimab monotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Experimental Arm (Radio-immunotherapy): Patients will receive neoadjuvant radiotherapy (SBRT 24 Gy in 3 fractions) followed by or concurrent with 2 cycles of Adebrelimab (1200mg, Q3W).
Control Arm (Immunotherapy alone): Patients will receive 2 cycles of Adebrelimab (1200mg, Q3W) as monotherapy.
Following the completion of neoadjuvant therapy, a multidisciplinary team (MDT) will evaluate the patients' response. Eligible patients will then undergo standard surgical resection of the primary tumor and neck dissection within 3 to 4 weeks after the last dose of immunotherapy.
The primary endpoint is the Major Pathological Response (MPR) rate, defined as less than or equal to 10% residual viable tumor in the resected specimen. Secondary endpoints include Pathological Complete Response (pCR) rate, Objective Response Rate (ORR) according to RECIST 1.1, Event-Free Survival (EFS), and the incidence of treatment-emergent adverse events (TEAEs) graded by CTCAE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, two-arm, parallel-assignment Phase II study. Eligible patients with locally advanced HNSCC will be randomized at a 1:1 ratio to receive either neoadjuvant Adebrelimab in combination with radiotherapy (Experimental Arm) or Adebrelimab monotherapy (Control Arm). Randomization will be stratified by [stratification factors, e.g., clinical stage (III vs. IV) or primary tumor site]. Both groups will undergo surgical resection following the completion of neoadjuvant therapy.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Radio-immunotherapy (Adebrelimab + RT) | Experimental | Drug: Adebrelimab, Radiation: radiotherapyPatients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) combined with radiotherapy (SBRT), followed by surgical resection. |
| Neoadjuvant Immunotherapy Monotherapy (Adebrelimab) | Active comparator | Drug: AdebrelimabPatients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) monotherapy, followed by surgical resection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC).
- Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer.
- PD-L1 expression with a Combined Positive Score (CPS) ≥ 1.
- Karnofsky Performance Status (KPS) score ≥ 70.
- Age between 18 and 70 years (inclusive).
Key exclusion criteria (5 listed)
- Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies.
- Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections.
- Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU/mL).
- Pregnant or breastfeeding women.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for 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 |
|---|---|---|
| AdebrelimabA humanized IgG4 monoclonal antibody against programmed cell death-ligand 1 (PD-L1). Dosage: 1200 mg administered via intravenous (IV) infusion on Day 1 of each 21-day cycle, for a total of 2 cycles in the neoadjuvant setting. | Drug | Neoadjuvant Immunotherapy Monotherapy (Adebrelimab), Neoadjuvant Radio-immunotherapy (Adebrelimab + RT) |
| radiotherapyNeoadjuvant radiotherapy targeting the primary tumor and involved cervical lymph nodes. (SBRT with a total dose of [24] Gy in [3] fractions). | Radiation | Neoadjuvant Radio-immunotherapy (Adebrelimab + RT) |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery (approximately 6-8 weeks after the first dose of neoadjuvant therapy).
The percentage of participants with 10% or less residual viable tumor cells in the resected primary tumor and lymph nodes following neoadjuvant therapy. Assessment will be performed by independent pathologists.
3 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery.
Objective Response Rate (ORR)
Time frame: From the first dose of neoadjuvant therapy until pre-operative clinical evaluation (approximately 6 weeks).
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the start of treatment up to 30 days after surgery.
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Chunyan Chen principal investigator
Sun Yat-Sen University Cancer Center
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 Adebrelimab and radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Chen Chunyan 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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 Apr 2026. 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 Anqi He, MB (+86-18025464619, heaq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: At the time of surgery (approximately 6-8 weeks after the first dose of neoadjuvant therapy).). 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 28 Apr 2026.