Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are:
Does the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC?
What adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy?
Does this combined therapy improve participants' objective response rate (ORR), survival time and quality of life?
This is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial.
Participants will:
Receive Sacituzumab govitecan (5mg/kg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles.
Patients will undergo surgical resection 3-6 weeks after completion of neoadjuvant therapy. Adjuvant therapy (concurrent chemoradiotherapy or radiotherapy alone) will be administered according to pathological risk factors, together with 15 cycles of Tagitanlimab as adjuvant immunotherapy.
Visit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI/CT) and safety checkups according to the study schedule.
Provide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection.
Complete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning.
Note: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years and above, of any gender.
Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin ≥8 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) >60 mL/min; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.
Disqualifiers
A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).
Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.
Prior anti-tumor treatment involving anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab Govitecan
DrugHumanized anti-TROP2 antibody-drug conjugate (ADC) linked to a topoisomerase I inhibitor via a stable linker, featuring high tumor targeting and efficient cytotoxic drug release. Administered intravenously at 5mg/kg every 2 weeks for 2 cycles (90±15 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), delivering targeted cytotoxic effects to TROP2-overexpressing tumor cells to inhibit tumor growth.
Tagitanlimab
DrugHumanized IgG1κ anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 signaling pathway to restore T cell-mediated anti-tumor immunity and reverse tumor immune escape. Administered intravenously at a fixed 900mg dose every 2 weeks for 2 cycles (120 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), used in combination with Sacituzumab Govitecan to achieve synergistic anti-tumor activity.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Sacituzumab govitecan + Tagitanlimab Neoadjuvant TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Major Pathological Response Rate (MPR)
Major Pathological Response Rate (MPR) is defined as the proportion of enrolled patients with residual viable tumor (RVT) ≤10% in the primary tumor and regional lymph node resection specimens after completion of 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per immune-related pathological response criteria (irPRC) by independent pathological reviewers. MPR is the primary efficacy endpoint to evaluate the anti-tumor activity of the combined neoadjuvant regimen in resectable head and neck squamous cell carcinoma (HNSCC).
Time frame
Assessed at the time of surgical resection (3 to 6 weeks after the completion of neoadjuvant therapy)Secondary outcomes
1
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of enrolled patients achieving a confirmed complete response (CR) or partial response (PR) in tumor lesions after 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent radiological reviewers. ORR reflects the short-term anti-tumor efficacy of the combined neoadjuvant regimen on measurable HNSCC lesions.
Time frame
Assessed at 3 to 6 weeks after the completion of neoadjuvant therapy (prior to surgical resection)2
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to the first occurrence of any study event, including radiologically or pathologically confirmed disease progression, local/distant tumor recurrence, or all-cause mortality. EFS evaluates the medium-term disease control efficacy of the combined regimen in resectable HNSCC patients.
Time frame
Assessed up to 2 years after the first dose of neoadjuvant therapy (with regular follow-up every 3-4 months)3
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to all-cause mortality in enrolled patients. OS is a key endpoint reflecting the long-term survival benefit of the combined neoadjuvant regimen for resectable HNSCC patients, with survival status monitored through regular clinical follow-up.
Time frame
Assessed up to 5 years after the first dose of neoadjuvant therapy (follow-up every 6 months for years 3-5, annually after year 5)4
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Incidence and severity of Treatment-Related Adverse Events (TRAEs) are defined as all adverse medical events judged to be related to Sacituzumab Govitecan and/or Tagitanlimab during the entire study period, graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. This endpoint evaluates the safety and tolerability of the combined neoadjuvant regimen in resectable HNSCC patients.
Time frame
Assessed from the first dose of neoadjuvant therapy to 90 days after the last study drug administration (with 30-day post-treatment safety follow-up)Sponsors and contacts
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Source ClinicalTrials.gov