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Circulating Tumor DNA-Informed Adjuvant Therapy for Intermediate-Risk Head and Neck Cancer

27 октября 2026 г. обновлено: Kevin Contrera

Phase II Trial of Drain Fluid Circulating Tumor DNA-Informed Adjuvant Therapy for Intermediate-Risk Head and Neck Cancer

This study is being done to determine whether an assay called LymphDetect™ Head and Neck is a useful tool to help guide treatment decisions for patients with head and neck cancer. The LymphDetect™ assay works to detect a certain kind of DNA that is released by tumors called circulating tumor DNA or ctDNA for short. In this study, the presence of ctDNA will be assessed in fluid collected from the surgical drain that will be placed during curative-intent surgical procedure performed as a part of patient standard care. Treatment after surgery is determined by a patient's disease risk category (low-risk, intermediate-risk, or high-risk). Having intermediate-risk with detection of ctDNA in the surgical drain fluid (SDF+) may mean that a patient is at greater risk of their cancer coming back. To reduce this risk, treatment will be more intensive than if ctDNA in the surgical drain fluid (SDF-) was not found.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

Patients who are Surgical Drain Fluid (SDF) positive have a more than eight-fold higher risk of Head and Neck Squamous Cell Carcinoma disease recurrence. Whether these pathologically intermediate-risk patients benefit from the addition of concurrent cisplatin to adjuvant radiotherapy is unknown. Various prognostic biomarkers have been proposed to identify patients at high risk of recurrence. Tissue-based biomarkers may be less prognostic after successful tumor extirpation. Several plasma-based ctDNA assays measuring treatment response in HPV- HNSCC are under investigation. However, data is limited on the role of such assays for the detection of molecular residual disease (MRD) after surgery, particularly for risk-informed adjuvant treatment decision making. Tumor-informed ctDNA from postoperative SDF, taken 24 hours after surgery, has been shown to be a promising biomarker for individualizing recurrence risk. The LymphDetect™ Head & Neck system, will be used to measure circulating tumor DNA (ctDNA) in surgical drain fluid, the most proximal biofluid to a recently resected tumor, to assess cancer recurrence risk at the source of potential spread - before it can travel to other parts of the body. There is a critical need to improve recurrence risk estimates for patients with HPV- HNSCC to inform the extent of adjuvant management, improve oncologic outcomes, and limit unnecessary treatment morbidity and mortality.

Тип исследования

Интервенционный

Регистрация (Оцененный)

140

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Jennifer Ruth, RN, BSN
  • Номер телефона: 412-623-8963
  • Электронная почта: ruthj2@upmc.edu

Учебное резервное копирование контактов

  • Имя: Mel J Mendez, RN, BSN
  • Номер телефона: 878-261-6071
  • Электронная почта: mendezmj@upmc.edu

Места учебы

  • Соединенные Штаты
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15232
        • UPMC Hillman Cancer Center
        • Контакт:
          • Jennifer Ruth, RN, BSN
          • Номер телефона: 412-623-8963
          • Электронная почта: ruthj2@upmc.edu
        • Контакт:
          • Mel J Mendez, RN, BSN
          • Номер телефона: 878-261-6071
          • Электронная почта: mendezmj@upmc.edu
        • Главный следователь:
          • Kevin J Contrera, MD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Must have histologically or cytologically confirmed newly diagnosed mucosal HNSCC (i.e., oral cavity, oropharynx, hypopharynx, or larynx).

    o Patients with intermediate-risk disease (stage cT2N0 with adverse pathologic features OR stage cT3-4Nany OR stage cTanyN1-3a) will be preferentially enrolled.

  2. Must have received no prior therapies for current malignancy, except for neoadjuvant pembrolizumab.

  3. Must be able to undergo curative-intent surgical resection with neck dissection and placement of a drain.

  4. Patient is considered a candidate for adjuvant chemotherapy (cisplatin) and radiation based on the clinical judgment of the treating investigator. This decision should be made based upon the patient's pre-operative assessment performed as part of the standard of care.

  5. Age ≥18 years.

  6. Performance status ECOG 0-2

  7. Sexually active, fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and for 30 days after the last dose of chemotherapy and/or radiation (whichever is later). In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.

  8. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:

    o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years of age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.

  9. Must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. HPV-related oropharyngeal cancer
  2. Nasopharyngeal cancer
  3. Sinonasal cancer
  4. Prior or recurrent HNSCC
  5. Distant metastasis
  6. Other active malignancy, other than nonmetastatic skin, prostate, or thyroid malignancy
  7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Low-Risk
Диагностический тест: LymphDetect assay

A tumor-informed ctDNA assay that uses Surgical Drain Fluid (SDF) collected 24 hours after the end of surgery to direct therapeutic intervention.

Процедура: Surgery +/- neoadjuvant pembrolizumab

Performed within 28 days after baseline assessment to remove Head and Neck Cancer tumor(s).
Экспериментальный: Intermediate Risk - Surgical Drain Fluid (negative)

IMRT or IMPT to 60 Gy in 30 fractions (2Gy/FX) ± Pembrolizumab - 200 mg q3w - Restart post-surgery (can begin prior to or at the same time as radiation therapy) and continue for up to 17 cycles (including neoadjuvant cycles).

[IMRT / IMPT Schedule to be determined by radiation oncologist, should be completed within 42 days of start date]
Диагностический тест: LymphDetect assay

A tumor-informed ctDNA assay that uses Surgical Drain Fluid (SDF) collected 24 hours after the end of surgery to direct therapeutic intervention.

Процедура: Surgery +/- neoadjuvant pembrolizumab

Performed within 28 days after baseline assessment to remove Head and Neck Cancer tumor(s).

Радиация: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT)

Advanced type of radiation therapy that uses powerful energy beams to kill cancer cells. The energy can come from X-rays, protons or other sources, in which the beams of radiation are carefully customized.

Лекарство: Pembrolizumab

Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively.

Другие имена:
  • Китруда®
Экспериментальный: Intermediate Risk - Surgical Drain Fluid (positive)

IMRT or IMPT to 60 Gy in 30 fractions (2Gy/FX) with concurrent cisplatin 40 mg/m^2 weekly for 6 doses or 3-weekly 100mg/m2 dose for 3 doses ± Pembrolizumab - 200 mg q3w - Restart post-surgery (can begin prior to or at the same time as radiation therapy) and continue for up to 17 cycles (including neoadjuvant cycles).

[Cisplatin: 40 mg/m^2 weekly (6 total doses) - Day 1, 8, 15, 22, 29, and 36 of radiation therapy or Cisplatin: 100 mg/m^2 q3w (3 total doses) - Day 1, 22, and 43 of radiation therapy (last dose of cisplatin may be after the last dose of radiation)] (If Cisplatin is not tolerated, Carboplatin AUC 2 weekly for 6 doses may be given.)
Диагностический тест: LymphDetect assay

A tumor-informed ctDNA assay that uses Surgical Drain Fluid (SDF) collected 24 hours after the end of surgery to direct therapeutic intervention.

Процедура: Surgery +/- neoadjuvant pembrolizumab

Performed within 28 days after baseline assessment to remove Head and Neck Cancer tumor(s).

Радиация: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT)

Advanced type of radiation therapy that uses powerful energy beams to kill cancer cells. The energy can come from X-rays, protons or other sources, in which the beams of radiation are carefully customized.

Лекарство: Pembrolizumab

Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively.

Другие имена:
  • Китруда®
Лекарство: Cisplatin or carboplatin

An alkylating agent that contains platinum, which binds to DNA in cancer cells, causing cross-links that prevent DNA replication and repair, leading to cell death, particularly in rapidly dividing cancer cells.

Другие имена:
  • Платинол®
Экспериментальный: High Risk

IMRT or IMPT to 60 Gy in 30 fractions (2Gy/FX) with concurrent cisplatin 40 mg/m^2 weekly for 6 doses or 3-weekly 100mg/m2 dose for 3 doses ± Pembrolizumab - 200 mg q3w - Restart post-surgery (can begin prior to or at the same time as radiation therapy) and continue for up to 17 cycles (including neoadjuvant cycles).

[Cisplatin: 40 mg/m^2 weekly (6 total doses) - Day 1, 8, 15, 22, 29, and 36 of radiation therapy or Cisplatin: 100 mg/m^2 q3w (3 total doses) - Day 1, 22, and 43 of radiation therapy (last dose of cisplatin may be after the last dose of radiation)]

(If Cisplatin is not tolerated, Carboplatin AUC 2 weekly for 6 doses may be given.)
Диагностический тест: LymphDetect assay

A tumor-informed ctDNA assay that uses Surgical Drain Fluid (SDF) collected 24 hours after the end of surgery to direct therapeutic intervention.

Процедура: Surgery +/- neoadjuvant pembrolizumab

Performed within 28 days after baseline assessment to remove Head and Neck Cancer tumor(s).

Радиация: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT)

Advanced type of radiation therapy that uses powerful energy beams to kill cancer cells. The energy can come from X-rays, protons or other sources, in which the beams of radiation are carefully customized.

Лекарство: Pembrolizumab

Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively.

Другие имена:
  • Китруда®
Лекарство: Cisplatin or carboplatin

An alkylating agent that contains platinum, which binds to DNA in cancer cells, causing cross-links that prevent DNA replication and repair, leading to cell death, particularly in rapidly dividing cancer cells.

Другие имена:
  • Платинол®

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
2-year Locoregional Control (LRC): SDF+ intermediate risk
Временное ограничение: At 2 years

Proportion of patients without locoregional recurrence (growth or recurrence of the primary tumor or other nearby structures within the same anatomical region or nearby regional lymph nodes) at 2 years from the initiation of study treatment in patients who are SDF+ intermediate risk.
At 2 years

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
2-year Locoregional Control (LRC): SDF- intermediate risk
Временное ограничение: At 2 years

Proportion of patients without locoregional recurrence (growth or recurrence of the primary tumor or other nearby structures within the same anatomical region or nearby regional lymph nodes) at 2 years from the initiation of study treatment in patients who are SDF-intermediate risk.
At 2 years
2-year Locoregional Control (LRC)
Временное ограничение: At 2 years

Proportion of all patients without disease recurrence (growth or recurrence of the primary tumor or other nearby structures within the same anatomical region or nearby regional lymph nodes) at 2 years from the initiation of study treatment.
At 2 years
2-year Event-free Survival (EFS): SDF+ intermediate risk
Временное ограничение: At 2 years

Proportion of patients without disease recurrence (growth or recurrence of the primary tumor and nearby regional lymph nodes or other nearby structures within the same anatomical region), progression, or death from any cause in SDF+ intermediate risk patients at 2 years from the initiation of study treatment.
At 2 years
2-year Event-free Survival (EFS): SDF- intermediate risk
Временное ограничение: At 2 year

Proportion of patients without disease recurrence (growth or recurrence of the primary tumor and nearby regional lymph nodes or other nearby structures within the same anatomical region), progression, or death from any cause in SDF- intermediate risk patients at 2 years from the initiation of study treatment.
At 2 year
2-year Event-free Survival (EFS)
Временное ограничение: At 2 years

Proportion of all patients without disease recurrence (growth or recurrence of the primary tumor and nearby regional lymph nodes or other nearby structures within the same anatomical region), progression, or death from any cause at 2 years from the initiation of study treatment.
At 2 years
2-year Overall Survival (OS): SDF+ intermediate risk
Временное ограничение: At 2 years

Proportion of SDF+ intermediate risk patients alive at 2 years from the initiation of study treatment.
At 2 years
2-year Overall Survival (OS): SDF- intermediate risk
Временное ограничение: At 2 years

Proportion of SDF- intermediate risk patients alive at 2 years from the initiation of study treatment.
At 2 years
2-year Overall Survival (OS)
Временное ограничение: At 2 year

Proportion of all patients alive at 2 years from the initiation of study treatment.
At 2 year
Incidence of Grade ≥ 3 Treatment-related Adverse Events (AE)
Временное ограничение: up to 30 days post-treatment

Number of (distinct) HNSCC patients with grade ≥ 3 Treatment-related Adverse Events (AE)s per CTCAE v5.0.
up to 30 days post-treatment

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Kevin Contrera

Соавторы

Droplet Biosciences, Inc.

Следователи

  • Главный следователь: Kevin J Contrera, MD, UPMC Cancer Center Hillman

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

15 ноября 2026 г.

Первичное завершение (Оцененный)

15 ноября 2028 г.

Завершение исследования (Оцененный)

15 ноября 2030 г.

Даты регистрации исследования

Первый отправленный

27 октября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

27 октября 2026 г.

Первый опубликованный (Действительный)

12 ноября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

12 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 октября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • HCC 26-056

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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