ClinicalTrialsFinder
RecruitingPhase 2NCT06170710

Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC

Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

173 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

Summary

This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • Histologically proven squamous cell carcinoma of the head and neck which include but not limit following primary sites: oral cavity, oropharynx, hypopharynx or larynx
  • Patients eligible with one or more High-Risk factors of the following: For HPV+ OPSCC: T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin\<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion；For HPV- HNSCC：T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin\<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion OR IV/V cervical lymph node metastases
  • ECOG performance score 0-1
  • PD-L1 expression with CPS\>1
  • No contraindications to immunotherapy or chemoradiotherapy
  • Adequate organ function
  • Female subject of childbearing potential should have a negative pregnancy test within 7 days prior to receiving the first dose of study medication.Female subjects of childbearing potential must be willing to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
  • Reproductive male subjects must agree to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
  • Informed consent is obtainable.

Exclusion Criteria10

  • Previous or co-existing malignancies, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer
  • Active infection
  • Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV
  • Active and/or historical autoimmune disease, except patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
  • Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study
  • History of PD-1/L1 treatment
  • If the subjects underwent major surgery for non-tumors, the toxicity and complications of the surgery needed to be adequately treated and the body conditions returned to normal
  • Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
  • Other circumstances leading to the termination of the study, as determined by the investigator

Interventions

DRUGAnti-PD-1 monoclonal antibody

Postoperative CCRT followed by any anti-PD-1 monoclonal antibody of the following: Pembrolizumab, 200mg, Q3W or Nivolumab, 3mg/kg, Q2W or Tislelizumab，200mg，Q3W or Camrelizumab，200mg，Q3W or Sintilimab，200mg，Q3W or Toripalimab，240mg，Q3W

OTHERPostoperative CCRT

Postoperative chemoradiotherapy

Locations(1)

National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06170710

Related Trials

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT069800383 locations

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

NCT0680685257 locations

Study of CHS-114 in Participants With Advanced Solid Tumors

NCT0563564316 locations

Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

NCT043753841 location

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

NCT0711504311 locations