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Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma

ConditionRecurrent Head and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYanjie Zhang, MD

About this trial

The goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally recurrent head and neck squamous cell carcinoma (HNSCC). The study will also evaluate the safety of this perioperative treatment approach.

The main questions it aims to answer are:

Does perioperative PD-1 antibody-based therapy improve event-free survival compared with the current standard treatment? What adverse events occur during treatment with neoadjuvant PD-1 antibody plus chemotherapy and adjuvant PD-1 antibody?

Researchers will compare a perioperative PD-1 antibody-based treatment strategy with the current standard treatment to determine which approach provides better clinical outcomes.

Participants will:

Be randomly assigned to one of two study groups. Receive either neoadjuvant PD-1 antibody plus chemotherapy followed by surgery and adjuvant PD-1 antibody, or undergo upfront surgery followed by standard postoperative treatment as indicated.

Visit the clinic regularly for physical examinations, blood tests, imaging assessments, and other study procedures.

Be followed after treatment to monitor disease status, treatment response, survival outcomes, and adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 80 years old (inclusive).

Primary Tumor: Histologically or cytologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma). Patients must have previously received surgery and/or radiotherapy.

Diagnosis: Locally recurrent or metastatic disease confirmed by pathology and/or imaging.

Clinical Stage: T1-4a, N0-2, M0 (AJCC TNM Staging System, 8th Edition), with no evidence of distant metastasis, and the recurrent lesion is assessed as surgically resectable.

Disqualifiers

Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways.

Presence of active severe autoimmune disease. Participants with conditions that are stable and do not require systemic immunosuppressive therapy are eligible, such as: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).

Has a congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or active hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).

Known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant PD-1 antibody plus chemotherapy

    Drug

    Administered once every 3 weeks for 2 to 4 cycles before surgery

  • surgery

    Procedure/Surgery

    Surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated.

  • Adjuvant PD-1 antibody

    Drug

    Administered postoperatively every 3 weeks for up to 15 cycles.

Treatment groups

217 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant ChemoimmunotherapyExperimental treatment 3 interventions
Group B: Upfront SurgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.

Time frame
2 years after randomization

Secondary outcomes

1

Overall Survival (OS)

Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive. OS will be estimated using the Kaplan-Meier method. The planned primary OS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.

Time frame
2 years after randomization
2

5-Year Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment or at 5 years after randomization, whichever occurs first. EFS will be estimated using the Kaplan-Meier method.

Time frame
5 years after randomization
3

5-Year Overall Survival (OS)

Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive or at 5 years after randomization, whichever occurs first. OS will be estimated using the Kaplan-Meier method.

Time frame
5 years after randomization
4

Adverse Events and Serious Adverse Events

The number and percentage of participants with adverse events and serious adverse events will be summarized. Events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Summaries will include event type, incidence, severity, onset and resolution dates, seriousness, relationship to study treatment, and outcome.

Time frame
From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yanjie Zhang, MD

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: