Health Trials

Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC

ConditionHead and Neck Squamous Cell Carcinoma HNSCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYanjie Zhang, MD

About this trial

This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years

Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)

Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable

ECOG sccore 0-1

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

Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)

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

Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant Finotonlimab Plus Chemotherapy

    Drug

    Participants receive neoadjuvant finotonlimab 200 mg intravenously on Day 1, albumin-bound paclitaxel 100 mg/m² intravenously on Days 1, 8, and 15, and carboplatin at an area under the concentration-time curve of 4 intravenously on Day 1 of each 21-day cycle for 2 cycles before surgery. Cisplatin 75 mg/m² intravenously on Day 1 may be substituted for carboplatin.

  • Surgery

    Procedure/Surgery

    Participants undergo definitive surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be administered according to postoperative pathological risk factors.

  • Postoperative Finotonlimab Maintenance

    Drug

    Participants receive postoperative finotonlimab 200 mg intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Treatment begins 3 to 6 weeks after surgery or, for participants receiving postoperative radiotherapy or concurrent chemoradiotherapy, within 2 weeks after completion of radiotherapy.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Upfront SurgeryActive comparator 1 intervention
Group B: Neoadjuvant Finotonlimab Plus ChemotherapyExperimental treatment 3 interventions

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

Major Pathological Response (MPR) Rate

The proportion of participants in the experimental-arm intention-to-treat population who achieve a major pathological response. MPR is defined as 10% or less residual viable tumor in the resected primary tumor and sampled regional lymph nodes, calculated as the area of residual viable tumor divided by the total tumor bed area.

Time frame
Within 2 weeks after surgery
3

Pathologic Complete Response (pCR) Rate

The proportion of participants in the experimental-arm intention-to-treat population who achieve a pathologic complete response. pCR is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes.

Time frame
Within 2 weeks after surgery
4

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

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

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