- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170710
Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC
Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This open-label, randomized, controlled, phase II study will include 173 patients who have been operated for their LA SCCHN with high risk.
Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT followed by/not PD-1 antibody.
The study is designed with the general objective of demonstrating that treatment CCRT followed by PD-1 antibody is more efficient than CCRT alone.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jingbo Wang, Dr.
- Phone Number: +861087787249
- Email: wangjingbo201001@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Jingbo Wang, Dr.
- Phone Number: +861087787249
- Email: wangjingbo201001@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the head and neck which include but not limit following primary sites: oral cavity, oropharynx, hypopharynx or larynx
- Patients eligible with one or more High-Risk factors of the following: For HPV+ OPSCC: T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion;For HPV- HNSCC:T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion OR IV/V cervical lymph node metastases
- ECOG performance score 0-1
- PD-L1 expression with CPS>1
- No contraindications to immunotherapy or chemoradiotherapy
- Adequate organ function
- Female subject of childbearing potential should have a negative pregnancy test within 7 days prior to receiving the first dose of study medication.Female subjects of childbearing potential must be willing to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
- Reproductive male subjects must agree to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
- Informed consent is obtainable.
Exclusion Criteria:
- Previous or co-existing malignancies, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer
- Active infection
- Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV
- Active and/or historical autoimmune disease, except patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study
- History of PD-1/L1 treatment
- If the subjects underwent major surgery for non-tumors, the toxicity and complications of the surgery needed to be adequately treated and the body conditions returned to normal
- Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
- Other circumstances leading to the termination of the study, as determined by the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RT+ cisplatin+Anti-PD-1 antibody
Concurrent cisplatin-RT followed by PD-1 antibody
|
Postoperative CCRT followed by any anti-PD-1 monoclonal antibody of the following: Pembrolizumab, 200mg, Q3W or Nivolumab, 3mg/kg, Q2W or Tislelizumab,200mg,Q3W or Camrelizumab,200mg,Q3W or Sintilimab,200mg,Q3W or Toripalimab,240mg,Q3W
Postoperative chemoradiotherapy
|
Active Comparator: RT+ cisplatin
Concurrent cisplatin-RT
|
Postoperative chemoradiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival at year 2 (2y-DFS)
Time Frame: From randomization until time of events up to 2 years
|
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence(including carcinoma in situ)or death from any cause.
|
From randomization until time of events up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Locoregional control at year 2 (2y-LRC)
Time Frame: From randomization until time of events up to 2 years
|
LRC defined from randomization to first radiographically or pathologically confirmed local or regional recurrence.
|
From randomization until time of events up to 2 years
|
Overall survival at year 2 (2y-OS)
Time Frame: From randomization until death due to any cause, up to 2 years
|
Time between the date of randomization and death.
|
From randomization until death due to any cause, up to 2 years
|
Adverse events
Time Frame: From randomization until time of events up to 2 years
|
Adverse events and serious adverse events according to CACTE 5.0.
|
From randomization until time of events up to 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jingbo Wang, Dr., National Cancer Cencer/Cancer hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Antibodies, Monoclonal
Other Study ID Numbers
- 23/219-3961
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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