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

NCT05777824 | Recruiting Phase 2

• 1 other identifier: 22/523-3725
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

postoperative radiotherapy; induction immunotherapy and chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  2 years

• Local-Regional failure survival

  2 years

• Toxicity Adverse events

  2 years

Study Arms (6)

low-risk and PCR

NO INTERVENTION

Observation

low-risk and MPR

EXPERIMENTAL

immunotherapy maintenance

Combination Product: anti-PD-1 or PD-L1 antibody

low-risk and IPR

EXPERIMENTAL

postoperative radiotherapy (50 Gy) and immunotherapy maintenance

Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy

high-risk and PCR

EXPERIMENTAL

postoperative radiotherapy (50 Gy) and immunotherapy maintenance

Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy

high-risk and MPR

EXPERIMENTAL

postoperative radiotherapy (60 Gy) and immunotherapy maintenance

Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy

high-risk and IPR

EXPERIMENTAL

postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance

Combination Product: anti-PD-1 or PD-L1 antibody; Radiation: postoperative radiaotherapy

Interventions

anti-PD-1 or PD-L1 antibody COMBINATION_PRODUCT

immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy

high-risk and IPR; high-risk and MPR; high-risk and PCR; low-risk and IPR; low-risk and MPR

postoperative radiaotherapy RADIATION

postoperative radiotherapy (60Gy or 50Gy)

high-risk and IPR; high-risk and MPR; high-risk and PCR; low-risk and IPR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

Beijin, Beijing Municipality, 51000, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Junlin Yi, Doctor

  National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

  STUDY CHAIR

Central Study Contacts

Yi Xu

CONTACT

15811166516; 694818945@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 21, 2023
• Study Start: January 1, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 11, 2023

Record last verified: 2023-02

Locations

CN (1)