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Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy (HN)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
anti-PD-1 or PD-L1 antibody
postoperative radiaotherapy
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring postoperative radiotherapy, induction immunotherapy and chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subjects are not limited by gender, age from 18 to 75 years old; Histopathologically confirmed squamous cell carcinoma of the head and neck cancer; Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging; ECOG score 0-1; without distant metastasis; received induction chemotherapy plus immunotherapy, followed by surgery The expected survival is expected to be no less than 6 months. No contraindications to chemotherapy, immunotherapy, and radiotherapy; Exclusion Criteria: Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ) Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy; Previously experienced head and neck radiation therapy; 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; 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; Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes

Sites / Locations

  • National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

low-risk and PCR

low-risk and MPR

low-risk and IPR

high-risk and PCR

high-risk and MPR

high-risk and IPR

Arm Description

Observation

immunotherapy maintenance

postoperative radiotherapy (50 Gy) and immunotherapy maintenance

postoperative radiotherapy (50 Gy) and immunotherapy maintenance

postoperative radiotherapy (60 Gy) and immunotherapy maintenance

postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance

Outcomes

Primary Outcome Measures

Disease-free survival
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.

Secondary Outcome Measures

Overall survival
defined as the time from random assignment to death from any cause or censored at the date of last follow-up.
Local-Regional failure survival
defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment.
Toxicity Adverse events
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0.

Full Information

First Posted
March 7, 2023
Last Updated
October 9, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05777824
Brief Title
Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy
Acronym
HN
Official Title
Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
postoperative radiotherapy, induction immunotherapy and chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-risk and PCR
Arm Type
No Intervention
Arm Description
Observation
Arm Title
low-risk and MPR
Arm Type
Experimental
Arm Description
immunotherapy maintenance
Arm Title
low-risk and IPR
Arm Type
Experimental
Arm Description
postoperative radiotherapy (50 Gy) and immunotherapy maintenance
Arm Title
high-risk and PCR
Arm Type
Experimental
Arm Description
postoperative radiotherapy (50 Gy) and immunotherapy maintenance
Arm Title
high-risk and MPR
Arm Type
Experimental
Arm Description
postoperative radiotherapy (60 Gy) and immunotherapy maintenance
Arm Title
high-risk and IPR
Arm Type
Experimental
Arm Description
postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance
Intervention Type
Combination Product
Intervention Name(s)
anti-PD-1 or PD-L1 antibody
Intervention Description
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
Intervention Type
Radiation
Intervention Name(s)
postoperative radiaotherapy
Intervention Description
postoperative radiotherapy (60Gy or 50Gy)
Primary Outcome Measure Information:
Title
Disease-free survival
Description
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
defined as the time from random assignment to death from any cause or censored at the date of last follow-up.
Time Frame
2 years
Title
Local-Regional failure survival
Description
defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment.
Time Frame
2 years
Title
Toxicity Adverse events
Description
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects are not limited by gender, age from 18 to 75 years old; Histopathologically confirmed squamous cell carcinoma of the head and neck cancer; Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging; ECOG score 0-1; without distant metastasis; received induction chemotherapy plus immunotherapy, followed by surgery The expected survival is expected to be no less than 6 months. No contraindications to chemotherapy, immunotherapy, and radiotherapy; Exclusion Criteria: Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ) Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy; Previously experienced head and neck radiation therapy; 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; 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; Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Xu
Phone
15811166516
Email
694818945@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junlin Yi, Doctor
Organizational Affiliation
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
City
Beijin
State/Province
Beijing
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jingbo
Phone
15811166516
Email
ivy2019xu@163.com
First Name & Middle Initial & Last Name & Degree
Xu Yi
Phone
15811166516
Email
ivy2019xu@163.com

12. IPD Sharing Statement

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Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy

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