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Trial Title:
Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
NCT ID:
NCT05777824
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Antibodies
Conditions: Keywords:
postoperative radiotherapy
induction immunotherapy and chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
anti-PD-1 or PD-L1 antibody
Description:
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13
cycles after radiotherapy
Arm group label:
high-risk and IPR
Arm group label:
high-risk and MPR
Arm group label:
high-risk and PCR
Arm group label:
low-risk and IPR
Arm group label:
low-risk and MPR
Intervention type:
Radiation
Intervention name:
postoperative radiaotherapy
Description:
postoperative radiotherapy (60Gy or 50Gy)
Arm group label:
high-risk and IPR
Arm group label:
high-risk and MPR
Arm group label:
high-risk and PCR
Arm group label:
low-risk and IPR
Summary:
To develop postoperative stratification treatment for patients who have received
induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk
stratification is based on clinical characteristics and pathological responses. In order
to achieve no inferior survival rate and a lower treatment-related toxicity rate than the
standard treatment.
Detailed description:
Induction chemotherapy combined with immunotherapy has shown promising efficacy in the
treatment of patients with locally advanced head and neck cancers. However, how to choose
a proper postoperative treatment remains unknown. Eligibility patients were assigned to
two arms, each divided into three groups: observation, immunotherapy maintenance, and
radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm;
radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent
chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free
survival, overall survival, and treatment-related toxicity would be calculated to
evaluate the efficacy of treatments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subjects are not limited by gender, age from 18 to 75 years old;
2. Histopathologically confirmed squamous cell carcinoma of the head and neck cancer;
3. Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to
AJCC 8th edition staging;
4. ECOG score 0-1;
5. without distant metastasis;
6. received induction chemotherapy plus immunotherapy, followed by surgery
7. The expected survival is expected to be no less than 6 months.
8. No contraindications to chemotherapy, immunotherapy, and radiotherapy;
Exclusion Criteria:
1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical
carcinoma in situ)
2. Received any systemic anti-tumor therapy for target lesions before induction
chemotherapy and immunotherapy;
3. Previously experienced head and neck radiation therapy;
4. Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent
hormones) or other immunosuppressive agents for systemic treatment within 1 month
before enrollment. In the absence of active autoimmune disease, inhaled or topical
corticosteroids and adrenal hormone replacement therapy at therapeutic doses of
prednisone ≤10 mg/day are permitted;
5. Patients with pleural effusion, pericardial effusion or ascites that need to be
drained with clinical symptoms, or who have received serous cavity effusion drainage
for the purpose of treatment within 2 weeks before enrollment;
6. Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular
disease, ulceration disease, mental disease and uncontrolled diabetes
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Address:
City:
Beijin
Zip:
51000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wang Jingbo
Phone:
15811166516
Email:
ivy2019xu@163.com
Contact backup:
Last name:
Xu Yi
Phone:
15811166516
Email:
ivy2019xu@163.com
Start date:
January 1, 2023
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05777824
