NCT06208826

Brief Summary

Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
40mo left

Started Sep 2023

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Sep 2023Sep 2029

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

January 7, 2024

Last Update Submit

March 1, 2026

Conditions

Head and Neck Cancer

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.

    up to 4 years

Secondary Outcomes (2)

  • Over survival (OS)

    up to 4 years

  • Toxicity Adverse events

    up to 1 year

Study Arms (2)

Toripalimab

EXPERIMENTAL

toripalimab, IV, 240mg, q3w, for 15 cycles

Drug: Toripalimab

SOC CCRT or radiotherapy

ACTIVE COMPARATOR

Standard concurrent radiochemotherapy or postoperative radiotherapy

Radiation: Radiation TherapyDrug: Cisplatin

Interventions

ToripalimabDRUG

Toripamab, IV, 240mg, every 3 weeks for 15 cycles

Toripalimab
Radiation TherapyRADIATION

Radiation Therapy

SOC CCRT or radiotherapy
CisplatinDRUG

Chemotherapy agent

SOC CCRT or radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and willing to give an informed consent for the study.
  • Males or females aged 18 to 80 years.
  • Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to 1.
  • Pathologically (histologically or cytologically) confirmed, non-metastatic diagnosis of squamous cell carcinoma of head and neck (SCCHN).
  • Achievement of major pathological reaponse (MPR) after surgery with neoadjuvant immunotherapy combined chemotherapy.
  • Adequate bone marrow, liver, and renal function:
  • Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 9.0g/dL, platelets ≥100000/μL; ALT and AST \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN； Creatinine clearance ≥ 60 ml/min； APTT≤ 1.5×ULN.

You may not qualify if:

  • Participant has metastatic/unresectable SCCHN.
  • Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
  • With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
  • With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
  • With active infection requiring systemic therapy.
  • Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

toripalimabRadiotherapyCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Xudong Wang, Dr.

CONTACT

+862223340123wxd.1133@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

January 7, 2024

First Posted

January 17, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2029

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)