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Head and Neck Squamous Cell CarcinomaPhase 2IDEAL-RTNCT07791602

Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy in Head and Neck Cancer

A Phase 2 study testing Camrelizumab, Platinum-based Chemotherapy plus PD-1 inhibitor and De-escalated Radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims to evaluate whether reducing the intensity of radiotherapy (de-escalated radiotherapy) after induction chemoimmunotherapy is not inferior to standard-dose radiotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab, Platinum-based Chemotherapy plus PD-1 inhibitor and De-escalated Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
6 sitesChina
Study dates
12 Jun 2026to Dec 2032
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

  • Patients with head and neck squamous cell carcinoma (HNSCC) who have completed 2-3 cycles of induction chemotherapy plus PD-1 inhibitor and achieved deep response.
  • Within 1 month of achieving deep response, subsequent concurrent chemoradiotherapy is determined by integrating MDT recommendation and patient's discretion.
  • 2. Age 18 to 75 years (including 75). 3. Histopathologically confirmed HNSCC (excluding nasopharyngeal carcinoma). 4. Clinical stage T1-2N2-3M0 or T3-4N0-3M0 (AJCC 8th edition). 5. HPV or P16 negative. 6. ECOG performance status 0 or 1. 7. No contraindications to immunotherapy or radiotherapy. 8. Adequate organ function as defined by:
  • WBC ≥ 3.0×10^9/L, ANC ≥ 2.0×10^9/L, PLT ≥ 100×10^9/L, HGB ≥ 90 g/L (no transfusion or G-CSF within 14 days).
  • TBIL ≤ 2.0×ULN, ALT/AST ≤ 2.5×ULN, BUN/CRE ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min.
  • INR or PT ≤ 1.5×ULN (or within therapeutic range for anticoagulation).
  • Myocardial enzymes within normal limits. 9. For women of childbearing potential: negative pregnancy test within 7 days prior to enrollment and use of effective contraception during treatment and for 2 months after last dose. Male participants must agree to use effective contraception for the same period.
  • 10. Willing to sign informed consent and comply with follow-up.

Who cannot join

  • Occurrence of ≥ G4 toxicities during induction therapy and not suitable to receiving subsequent concurrent chemoradiotherapy or immunotherapy.
  • History of another active malignancy within 5 years, except cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, or superficial bladder cancer.
  • Active or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism/hypothyroidism requiring hormone replacement). Exceptions: vitiligo, childhood asthma fully resolved without intervention; asthma requiring bronchodilator medical intervention is excluded.
  • Uncontrolled cardiovascular disease: myocardial ischemia grade II or higher, myocardial infarction, poorly controlled arrhythmia (including QTc ≥ 470 ms), NYHA class III-IV heart failure, LVEF < 50%, or myocardial infarction within 1 year.
  • Active infection or unexplained fever >38.5°C during screening (tumor fever allowed if judged by investigator).
  • Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10^4 copies/mL), or active hepatitis C (HCV-RNA above lower limit of detection).
Show all 11Show fewer
  • Prior treatment with any PD-1/PD-L1 inhibitor.
  • Allergy to cisplatin, macromolecular protein preparations, or any component of anti-PD-1 antibodies.
  • Major surgery for non-tumor reasons without full recovery of toxicity/complications before starting study treatment.
  • Pregnancy or breastfeeding.
  • Any other condition that, in the investigator's judgment, would interfere with study participation or data collection (e.g., severe psychiatric illness, abnormal laboratory values, family or social factors).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Air Force Medical Center

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Harbin Medical University Cancer Hospital

    Harbin

  • Cancer Hospital of Dalian University of Technology （Liaoning Cancer Hospital & Institute）

    Shenyang

  • Shanxi Cancer Hospital

    Taiyuan

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

Other trials in China

About this study

Official title: Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy (IDEAL-RT) in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Phase II, Randomized Non-Inferiority Controlled Trial

This study aims to evaluate whether reducing the intensity of radiotherapy (de-escalated radiotherapy) after induction chemoimmunotherapy is not inferior to standard-dose radiotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The study is a multicenter, prospective, phase II, randomized, non-inferiority controlled trial. A total of 180 participants who achieve deep tumor response (≥50% regression) after 2-3 cycles of induction chemotherapy plus PD-1 inhibitor (camrelizumab) will be randomized 1:1 to receive either de-escalated radiotherapy (experimental group) or standard radiotherapy (control group). Additional maintenance camrelizumab for 8 cycles after radiotherapy will be administered for both groups. The primary outcome is 2-year progression-free survival (PFS). Secondary outcomes include overall survival, local-regional control, distant metastasis-free survival, treatment-related adverse events, and quality of life. The study is expected to start in June 2026 and complete in December 2031.

Read the detailed description

Background Induction chemoimmunotherapy has demonstrated marked response rates in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Conventional "expanded and escalated " radiotherapy to lymph node regions may reduce the systemic immune responses. Therefore, de-escalated radiotherapy after a good response to induction therapy may reduce accumulated toxicity while preserving efficacy and maintain the functional state of anti-tumor immune niche.

Objectives Primary: To determine if de-escalated radiotherapy is non-inferior to standard radiotherapy for 2-year PFS in LA-HNSCC patients with deep response (≥50% tumor regression) after induction chemoimmunotherapy.

Secondary: To compare overall survival (OS), local-regional control (LRC), distant metastasis-free survival (DMFS), treatment-related adverse events (AEs, irAEs, SAEs), and quality of life (ECOG, EQ-5D-5L, MDADI) between the two groups.

Study Design Multicenter (8 sites in China), prospective, phase II, randomized (1:1), open-label, non-inferiority trial.

Eligibility Criteria:

  • Age 18-75 years
  • Histologically confirmed HNSCC (non-nasopharyngeal), HPV/P16 negative
  • AJCC 8th stage T1-2N2-3M0 or T3-4N0-3M0
  • ECOG 0-1
  • Completed 2-3 cycles of induction chemotherapy (platinum-based) plus PD-1 inhibitor, achieving deep response (≥50% tumor reduction by RECIST) assessed by MDT
  • Adequate organ function
  • No prior immunotherapy

Interventions:

Induction (all patients) : 2-3 cycles of chemotherapy (cisplatin/carboplatin based) + PD-1 inhibitor.

Randomization (1:1):

  • Experimental (de-escalated RT):

GTV (post-induction residual): 60 Gy/25 fractions GTVtb (pre-induction tumor bed): not specified CTV1 (GTVtb + 1 cm): 50 Gy/25 fractions CTV2 (high-risk nodal stations + one station beyond): 45 Gy/25 fractions

  • Control (standard RT):

GTV (post-induction residual): 69.96 Gy/33 fractions GTVtb (pre-induction tumor bed): not specified CTV1 (GTVtb + 1-1.5 cm + high-risk nodal stations): 60.06 Gy/33 fractions CTV2 (intermediate/low-risk nodal stations): 50.96 Gy/28 fractions

  • Maintenance: Camrelizumab 200 mg IV Q3W for 8 cycles

Follow-up: Every 3 months for 2 years post-RT.

Sample Size: 180 participants, 90 patients in each arm.

Statistical Analysis: Baseline comparisons using Mann-Whitney U test; survival analysis using log-rank test and Cox regression; non-inferiority testing for PFS.

Study Period: June 2026 (anticipated start) to December 2031 (completion).

Ethics: Approved by the Ethics Committee of Cancer Hospital, Chinese Academy of Medical Sciences (26/057-0382). Written informed consent will be obtained from all participants.

Being tested
Camrelizumab, Platinum-based Chemotherapy plus PD-1 inhibitor, De-escalated Radiotherapy, Standard Radiotherapy
Keywords
Induction Chemoimmunotherapy, De-escalated Radiotherapy, Camrelizumab, PD-1 Inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Camrelizumab 200 mg IV every 3 weeks for 8 cycles after radiotherapy as maintenance.

  • Platinum-based Chemotherapy plus PD-1 inhibitorDrug

    Cisplatin or carboplatin based chemotherapy combined with PD-1 inhibitor for 2-3 cycles as induction therapy.

  • De-escalated RadiotherapyRadiation

    Total dose 60 Gy to GTV (post-induction residual) in 25 fractions; CTV1 50 Gy/25 fractions; CTV2 45 Gy/25 fractions.

  • Standard RadiotherapyRadiation

    Total dose 69.96 Gy to GTV (post-induction residual) in 33 fractions; CTV1 60.06 Gy/33 fractions; CTV2 50.96 Gy/28 fractions.

Study groups in NCT07791602
Study groupRoleWhat they receive
De-escalated RadiotherapyExperimentalParticipants receive de-escalated definitive radiotherapy after induction chemoimmunotherapy. Total dose 60 Gy to GTV (post-induction residual) in 25 fractions; CTV1 50 Gy/25 fractions; CTV2 45 Gy/25 fractions. Followed by camrelizumab maintenance 200 mg IV Q3W for 8 cycles.
Receives: Drug: Camrelizumab; Drug: Platinum-based Chemotherapy plus PD-1 inhibitor; Radiation: De-escalated Radiotherapy
Standard RadiotherapyActive comparatorParticipants receive standard definitive radiotherapy after induction chemoimmunotherapy. Total dose 69.96 Gy to GTV (post-induction residual) in 33 fractions; CTV1 60.06 Gy/33 fractions; CTV2 50.96 Gy/28 fractions. Followed by camrelizumab maintenance 200 mg IV Q3W for 8 cycles.
Receives: Drug: Camrelizumab; Drug: Platinum-based Chemotherapy plus PD-1 inhibitor; Radiation: Standard Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) at 2 year

    PFS is defined as the time from randomization to the first documented disease progression (according to RECIST v1.1) or death from any cause, whichever occurs first. Participants who are alive and progression-free at 2 years will be censored.

    Measured: 2 years after randomization

Secondary outcomes (4)

  1. Overall Survival (OS) at 2 year

    Time from randomization to death from any cause. Participants alive at 2 years will be censored.

    Measured: 2 years after randomization

  2. Locoregional progression free survival (LRPFS) rate at 2 year

    LRPFS is defined as the time from randomization to the first documented local or regional disease progression (according to RECIST v1.1) or death from any cause, whichever occurs first. Participants who are alive and progression-free at 2 years will be censored.

    Measured: 2 years after randomization

  3. Distant Metastasis-Free Survival (DMFS) at 2 year

    Time from randomization to first detection of distant metastasis or death, whichever occurs first.

    Measured: 2 years after randomization

  4. Incidence of Treatment-Related Adverse Events

    Percentage of participants with adverse events (AEs), immune-related AEs (irAEs), and serious AEs (SAEs) graded according to CTCAE v5.0.

    Measured: From the start of radiotherapy until 90 days after last dose of camrelizumab.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start12 Jun 2026
  3. Primary completionJun 2031 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

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
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791602
Sponsor's protocol ID
IDEAL-RT
Acronym
IDEAL-RT
Status last verified
May 2026
First submitted
14 Jun 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Darragh LB, Karam SD. Radiation as an immune modulator: mechanisms and implications for combination with immunotherapy. Nat Rev Cancer. 2026 Apr;26(4):270-284. doi: 10.1038/s41568-025-00903-x. Epub 2026 Jan 23.

    PubMed 41577962

  • Wu D, Li Y, Xu P, Fang Q, Cao F, Lin H, Li Y, Su Y, Lu L, Chen L, Li Y, Zhao Z, Hong X, Li G, Tian Y, Sun J, Yan H, Fan Y, Zhang X, Li Z, Liu X. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Commun. 2024 Mar 11;15(1):2177. doi: 10.1038/s41467-024-46444-z.

    PubMed 38467604

  • Gong H, Tian S, Ding H, Tao L, Wang L, Wang J, Wang T, Yuan X, Heng Y, Zhang M, Shi Y, Xu C, Wu C, Wang S, Zhou L. Camrelizumab-based induction chemoimmunotherapy in locally advanced stage hypopharyngeal carcinoma: phase II clinical trial. Nat Commun. 2024 Jun 19;15(1):5251. doi: 10.1038/s41467-024-49121-3.

    PubMed 38898018

  • Rosenberg AJ, Juloori A, Jelinek MJ, Agrawal N, Cursio JF, Cipriani N, Lingen MW, Izumchenko E, Katipally R, Chin J, Ginat D, Pasternak-Wise O, Gooi Z, Blair E, Pearson AT, Haraf DJ, Vokes EE. Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2025 May 1;11(5):492-501. doi: 10.1001/jamaoncol.2025.0081.

    PubMed 40048190

  • Galluzzi L, Aryankalayil MJ, Coleman CN, Formenti SC. Emerging evidence for adapting radiotherapy to immunotherapy. Nat Rev Clin Oncol. 2023 Aug;20(8):543-557. doi: 10.1038/s41571-023-00782-x. Epub 2023 Jun 6.

    PubMed 37280366

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Platinum-based Chemotherapy plus PD-1 inhibitor and De-escalated Radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 6 sites 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 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) at 2 year (time frame: 2 years after randomization). 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 NCT07791602, which also lists 5 linked publications.

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 Aug 2026.

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