Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC

NCT06170710 | Recruiting Phase 2

• 1 other identifier: 23/219-3961
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease free survival at year 2 (2y-DFS)

  Disease-free survival time is defined as the time from date of randomization until the first disease recurrence（including carcinoma in situ）or death from any cause.

  From randomization until time of events up to 2 years

Secondary Outcomes (3)

• Locoregional control at year 2 (2y-LRC)

  From randomization until time of events up to 2 years

• Overall survival at year 2 (2y-OS)

  From randomization until death due to any cause, up to 2 years

• Adverse events

  From randomization until time of events up to 2 years

Study Arms (2)

RT+ cisplatin+Anti-PD-1 antibody

EXPERIMENTAL

Concurrent cisplatin-RT followed by PD-1 antibody

Drug: Anti-PD-1 monoclonal antibody; Other: Postoperative CCRT

RT+ cisplatin

ACTIVE COMPARATOR

Concurrent cisplatin-RT

Other: Postoperative CCRT

Interventions

Anti-PD-1 monoclonal antibody DRUG

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

RT+ cisplatin+Anti-PD-1 antibody

Postoperative CCRT OTHER

Postoperative chemoradiotherapy

RT+ cisplatin; RT+ cisplatin+Anti-PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Jingbo Wang, Dr.

  National Cancer Cencer/Cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingbo Wang, Dr.

CONTACT

+861087787249; wangjingbo201001@163.com

Study Design

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

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)