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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05777824

Collaborator

(none)

Enrollment

Location

Arms

57.4

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Combination Product: anti-PD-1 or PD-L1 antibody Radiation: postoperative radiaotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: low-risk and PCR Observation
Experimental: low-risk and MPR immunotherapy maintenance	Combination Product: anti-PD-1 or PD-L1 antibody immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
Experimental: low-risk and IPR postoperative radiotherapy (50 Gy) and immunotherapy maintenance	Combination Product: anti-PD-1 or PD-L1 antibody immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy Radiation: postoperative radiaotherapy postoperative radiotherapy (60Gy or 50Gy)
Experimental: high-risk and PCR postoperative radiotherapy (50 Gy) and immunotherapy maintenance	Combination Product: anti-PD-1 or PD-L1 antibody immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy Radiation: postoperative radiaotherapy postoperative radiotherapy (60Gy or 50Gy)
Experimental: high-risk and MPR postoperative radiotherapy (60 Gy) and immunotherapy maintenance	Combination Product: anti-PD-1 or PD-L1 antibody immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy Radiation: postoperative radiaotherapy postoperative radiotherapy (60Gy or 50Gy)
Experimental: high-risk and IPR postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance	Combination Product: anti-PD-1 or PD-L1 antibody immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy Radiation: postoperative radiaotherapy postoperative radiotherapy (60Gy or 50Gy)

Outcome Measures

Primary Outcome Measures

Disease-free survival [2 years]
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 [2 years]
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 [2 years]
defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment.
Toxicity Adverse events [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC	Beijin	Beijing	China	51000

Sponsors and Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Study Chair: Junlin Yi, Doctor, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05777824

Other Study ID Numbers:

22/523-3725

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences

postoperative radiotherapy

induction immunotherapy and chemotherapy

Additional relevant MeSH terms:

Head and Neck Neoplasms

Antibodies

Study Results

No Results Posted as of Mar 21, 2023