- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476965
Selected De-escalation Radiotherapy for Postoperative Head and Neck Squamous Cell Carcinoma (iCSDeR)
July 25, 2022 updated by: Yu Qian, Hubei Cancer Hospital
A Phase II Trial of Cisplatinum, Paclitaxel, and Sintilimab Induction Therapy Followed by De-escalation Radiotherapy for Patients With Postoperative Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuan Wu, Dr.
- Phone Number: 862787670318
- Email: 344351420@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Hubei Cancer Hospital
-
Contact:
- Yuan Wu, Dr.
- Phone Number: 862787670318
- Email: 344351420@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the age of 18 to 65.
- Newly diagnosed pathologically confirmed locally advanced head and neck squamous cell carcinoma, including oral cancer, oropharyngeal cancer, laryngeal cancer, while nasopharyngeal carcinoma was excluded. The P16 status of oropharyngeal carcinoma is known.
- Locally advanced resectable head and neck tumors (stage III and stage IV) were enrolled and radiotherapy is expected to be performed within 4 or 6 weeks after surgery. Tumor staging is based on AJCC/UICC 8th Edition. All the patients must undergo the following examinations to determine the tomor stage before the treatment: complete medical history, physical examination, blood and biochemical routine, head and neck CT or MRI, chest CT scan, abdominal ultrasound and bone scan. In addition, 18F PET/CT can be used to replace the last three imaging examinations mentioned above.
- ECOG performance status 0 or 1.
Normal Organ function
- Leukocytes ≥ 4×109/L
- Hemoglobin ≥ 90 g/L
- Platelets ≥ 100×109/L
- Total bilirubin ≤ 1.5x upper limit of normal
- Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) ≤ 2.5x upper limit of normal
- Alkaline phosphatase ≤ 2.5x upper limit of normal
- Creatinine clearance > 60 mL/min
- Normal thyroid function, amylase, pituitary function, inflammation and infection index, myocardial enzyme, and ECG. For patients with abnormal ECG or cardiovascular history but not meet the exclusion criteria, a cardiac color ultrasound is needed, and the results should be normal.
- Patients must sign an informed consent form prior to study entry and they must be willing to comply with the visit, treatment protocol, laboratory examination and other requirements included in the study protocol.
- Women of childbearing potential and men with fertility partners must agree to follow instructions for methods of contraception (such as condoms or contraceptive drugs) from screening to 1 years after completing treatment.
Exclusion Criteria:
- Positive HBsAg and HBV DNA > 1×103 copies/ml, or anti-HCV antibody positive.
- Positive anti-HIV antibody or diagnosed as AIDS.
- patients with active tuberculosis history (whether treated or not) in the past 1 years, or with a history of tuberculosis more than 1 years (except those who had received regular anti-tuberculosis treatment).
- Has active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) are not included.
- Diagnosis of interstitial pneumonia or pneumonia and receiving oral or intravenous steroid therapy in the past 1 year.
- Receiving systemic glucocorticoid (10 mg prednisone per day) therapy or any other form of immunosuppressive therapy (excluding inhaled or topical corticosteroids).
- Uncontrolled heart disease, such as: heart failure, NYHA level ≥ 2; instability Angina pectoris; myocardial infarction history in the past 1 year; supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
- Pregnant or breastfeeding female patients (women of childbearing potential must have urine pregnancy test).
- Suffering from other malignant tumors at previously or currently. Additionally, well treated non melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer are not included.
- Allergic to macromolecular protein or any component of anti-PD1 antibody.
- Active infection requiring systemic therapy no more than one week.
- Has received a live vaccine within 30 days before administrating anti-PD-1 antibody.
- organ transplantation history.
- Other situations assessed by the investigator that may endanger patient safety or compliance, such as serious diseases requiring treatment (including mental diseases), serious abnormal test results, or with other family or social high-risk factor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
De-escalation radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: De-escalation radiotherapy
|
Radiotherapy: de-escalation radiotherapy or standard radiotherapy
|
Active Comparator: Arm 2
Arm 2 Standard radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: Standard radiotherapy
|
Radiotherapy: de-escalation radiotherapy or standard radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological complete response rate (pCR)
Time Frame: 3 weeks
|
pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen.
The objective is to intensify induction chemotherapy with the addition of anti-PD-1 McAb sintilimab aimed at acquiring a higher postoperative pCR.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation dose of normal organs and treatment-related adverse events
Time Frame: 12 months
|
Assess the radiation dose of normal organs between the de-escalation radiotherapy group or standard radiotherapy group.
Furthermore, toxicities reaction between two groups also been compared.
Adverse events were any untoward medical occurrence in a participant who received study interventions without regard to possibility of causal relationship.
|
12 months
|
Safety of sintilimab in combination with chemotherapy
Time Frame: 12 months
|
Evaluate the safety of sintilimab in combination with chemotherapy followed by surgery and radiotherapy in advanced head and neck squamous cell carcinoma patients.
|
12 months
|
Functional assessment of cancer therapy scale head and neck quality of life assessments
Time Frame: 6 months after the use of anti-PD-1 McAb sintilimab
|
Evaluate quality of life in all patients.
The specific modules H&N35 in Quality of Life Questionnaire Core 30 module (QLQ-C30) and European Organization for Research and Treatment of Cancer (EORTC) and Functional Assessment of Cancer Therapy (FACT) H&N V4.0 were used.
Both of them are standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.
|
6 months after the use of anti-PD-1 McAb sintilimab
|
Progression free survival (PFS) in 2 years
Time Frame: 24 months
|
PFS was defined as the time from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first.
Comparing the PFS at 24 months after completing chemotherapy, surgery, and radiotherapy between arm 1 and arm 2.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Desheng Hu, Dr., Hubei Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
July 25, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN010815
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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