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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Combination product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yi Xu; Phone Number: 15811166516; Email: 694818945@qq.com

Study Locations

• China
  • Beijing
    • Beijin, Beijing, China, 51000
      • Recruiting
      • National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
      • Contact: Wang Jingbo; Phone Number: 15811166516; Email: ivy2019xu@163.com
      • Contact: Xu Yi; Phone Number: 15811166516; Email: ivy2019xu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	defined as the time from random assignment to death from any cause or censored at the date of last follow-up.	2 years
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.	2 years
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.	2 years

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: postoperative radiotherapy; induction immunotherapy and chemotherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 22/523-3725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No