Can less radiation be enough after chemoimmunotherapy for head and neck cancer?
NCT ID NCT07791602
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests whether giving a lower dose of radiation after initial chemoimmunotherapy can control advanced head and neck cancer as well as the standard higher dose. Adults with head and neck squamous cell carcinoma who respond well to 2-3 cycles of chemotherapy plus the immunotherapy drug camrelizumab will be randomly assigned to receive either reduced-dose or standard-dose radiation. Both groups then continue camrelizumab for several months. The main goal is to compare how long participants live without the cancer progressing over two years, while also tracking side effects and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Camrelizumab (a PD-1 inhibitor) combined with platinum-based chemotherapy, followed by either reduced-dose or standard-dose radiation therapy.
- What this could lead to
- If successful, this could show that many patients with advanced head and neck cancer can safely receive less radiation, reducing long-term side effects while maintaining cancer control.
- What could go wrong
- This is a phase II trial with 180 participants, so results are preliminary. The reduced radiation might not control the cancer as well as standard treatment, and the immunotherapy can cause immune-related side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: 1. Occurrence of ≥ G4 toxicities during induction therapy and not suitable to receiving subsequent concurrent chemoradiotherapy or immunotherapy. 2. 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. 3. 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. 4. 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. 5. Active infection or unexplained fever \>38.5°C during screening (tumor fever allowed if judged by investigator). 6. 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). 7. Prior treatment with any PD-1/PD-L1 inhibitor. 8. Allergy to cisplatin, macromolecular protein preparations, or any component of anti-PD-1 antibodies. 9. Major surgery for non-tumor reasons without full recovery of toxicity/complications before starting study treatment. 10. Pregnancy or breastfeeding. 11. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Air Force Medical Center
Beijing, China
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Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
Shenyang, China
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Harbin Medical University Cancer Hospital
Harbin, China
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Peking Union Medical College Hospital
Beijing, China
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Shanxi Cancer Hospital
Taiyuan, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): an open label, single-arm, phase II clinical trial
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