18 and older, any sex, with Advanced Head and Neck Squamous Cell Carcinoma or Recurrent Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response -Primary· Up to 2 years
Overall response will be measured according to RECIST 1.1 criteria to determine the percentage of participants with either a partial or complete response and the corresponding 95% Clopper-Pearson exact confidence interval. The best overall response is the best response recorded from the start of the treatment across all time points.
COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are ta
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
40.0
16.3 – 67.7
Response Rate in the Target LesionsSecondary· Up to 2 years
Response rate will be measured as the following:
Complete: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Partial: At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases with
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
40.0
16.3 – 67.7
Response Rate in the Non-Target LesionsSecondary· Up to 2 years
Response rate will be measured using RECIST 1.1:
Complete: Disappearance (or decrease to the point at which measurement is not possible) of all non-target lesions. All lymph nodes must be non-pathological in size (\< 10 mm short axis).
Partial: Non-complete response/Non-progressive disease: Persistence of 1 or more non-target lesion(s).
Progressive Disease: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
10
0.3 – 44.5
Duration of Response at the Target Lesions - Mean MeasurementSecondary· Up to 2 years
For the duration of response, among participants investigators will estimate both the mean duration and the corresponding 95% confidence intervals for the mean and inter-quartile range for the median. The duration of response at the target lesion will be defined as the duration from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date of recurrent or progressive disease.
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
11.6
3.89 – 19.31
Duration of Response at the Target Lesions - Median MeasurementSecondary· Up to 2 years
The duration of response at the target lesion(s) will be defined as the duration from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date of recurrent or progressive disease. For the duration of response, among participants investigators will estimate the median duration and the corresponding 95% confidence intervals for the mean and inter-quartile range for the median.
Target Lesions:
COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathol
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
9.44
4.37 – 22.98
Progression-Free SurvivalSecondary· Up to 2 years.
For progression-free survival investigators will estimate Kaplan Meier survival curves and the median time to progression-free survival, as well as survival rates at 6 months and 1 year post treatment. Progression-Free Survival is defined as the duration of time from registration to the time of progression, death, or date of last contact; those lost to follow-up will be censored.
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
9.2
3.4 – 17.2
Progression-Free Survival - Survival Rate PercentagesSecondary· Up to 2 years.
For progression-free survival investigators will estimate Kaplan Meier survival curves and the median time to progression-free survival, as well as survival rates at 6 months and 1 year post treatment. Progression-Free Survival is defined as the duration of time from registration to the time of progression, death, or date of last contact; those lost to follow-up will be censored.
6 months survival
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
12
12 months survival
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
Overall Survival - MonthsSecondary· Up to 2 years
For time to event measure of overall survival investigators will estimate Kaplan Meier survival curves and the median time to overall survival, as well as survival rates at 6 months and 1 year post treatment. Overall Survival is defined as the duration of time from registration to date of death or date of last contact; those lost to follow-up will be censored.
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
14.9
4.9 – 25.8
Overall Survival - Survival Rate PercentagesSecondary· Up to 2 years
For time to event measure of overall survival investigators will estimate Kaplan Meier survival curves and the median time to overall survival, as well as survival rates at 6 months and 1 year post treatment. Overall Survival is defined as the duration of time from registration to date of death or date of last contact; those lost to follow-up will be censored.
6 months
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
14
12 months
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
10
Tolerability - Adverse Events Assessed Using PRO-CTCAE Version 5.0Secondary· Up to 2 years
Tolerability of intervention will be assessed using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Event (PRO CTCAE). Investigators will estimate the percentage of patients with different adverse events using a 95% Clopper Pearson exact confidence level. Listed adverse events were grade 3+ and deemed at least possibly related to therapy.
Leukocytosis
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Dysphagia
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
27
8 – 55
Abdominal Pain
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Dry Mouth
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Nausea
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Fatigue
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Infection
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Weight Loss
Group
Value
95% CI
Quad-shot Palliative Radiotherapy and Immunotherapy
7
0 – 32
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were recorded with each treatment cycle, up to 2 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Quad-shot Palliative Radiotherapy and Immunotherapy
Serious: 15/20 (75%)
Deaths: 13/20
Serious adverse events (24 terms)
Reaction
System
Quad-shot Palliative Radio…
Death
General disorders
—
Disease progression
General disorders
—
Dysphagia
Gastrointestinal disorders
—
Infections and Infestations
Infections and infestations
—
Weight Loss
Investigations
—
Paresthesia
Nervous system disorders
—
Floaters
Eye disorders
—
Abdominal Pain
Gastrointestinal disorders
—
Colonic perforation
Gastrointestinal disorders
—
Oral hemorrhage
Gastrointestinal disorders
—
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
—
Tracheostomy site bleeding
Injury, poisoning and procedural complications
—
Hypercalcemia
Metabolism and nutrition disorders
—
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
—
Tumor Hemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Facial muscle weakness
Nervous system disorders
—
Headache
Nervous system disorders
—
Stroke
Nervous system disorders
—
Vasovagal Reaction
Nervous system disorders
—
Hemorrhage
Respiratory, thoracic and mediastinal disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Respiratory Aspiration
Respiratory, thoracic and mediastinal disorders
—
Bullous (Dermatitis) Pemphigoid
Skin and subcutaneous tissue disorders
—
Thromboembolic Event
Vascular disorders
—
Other adverse events (71 terms — click to expand)
Reaction
System
Quad-shot Palliative Radio…
Fatigue
General disorders
—
Lymphocyte count decrease
Investigations
—
Dry mouth
Gastrointestinal disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
Anemia
Blood and lymphatic system disorders
—
Hypertension
Vascular disorders
—
Hyponatremia
Metabolism and nutrition disorders
—
Dysphagia
Gastrointestinal disorders
—
Pruritus
Skin and subcutaneous tissue disorders
—
Weight loss
Investigations
—
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 19 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04454489.