Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC

NCT ID: NCT06725498

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2029-11-30

Brief Summary

This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in conjunction with radiotherapy, succeeded by a series of immune checkpoint inhibitors. The efficacy and safety of this integrated therapeutic strategy are meticulously assessed, with the goal of enhancing survival outcomes for patients with T4bNanyM0 HNSCC.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT + IAC + Anti-PD-1 antibody

Patients must undergo Multi-Disciplinary Treatment evaluation after receiving 3 cycles of neoadjuvant therapy (Tislelizumab-jsgr combined with platinum-based chemotherapy).

For operable patients, Radical surgery followed by adjuvant standard (chemo)radiotherapy plus Tislelizumab-jsgr (Q3W 17 cycles).

For inoperable patients, Intra-arterial Chemotherapy concurrent with Radical radiotherapy followed by Tislelizumab-jsgr (Q3W 17 cycles).

Group Type: EXPERIMENTAL

Tislelizumab-jsgr

Intervention Type: DRUG

200mg, Q3W

Cisplatin

Intervention Type: DRUG

60-75 mg/㎡, Q3W

Albumin-Bound Paclitaxel

Intervention Type: DRUG

260 mg/㎡, Q3W

Radiotherapy

Intervention Type: RADIATION

Radical Radiotherapy or adjuvant Radiotherapy per guidelines.

Interventions

Tislelizumab-jsgr

200mg, Q3W

Intervention Type: DRUG

Cisplatin

60-75 mg/㎡, Q3W

Intervention Type: DRUG

Albumin-Bound Paclitaxel

260 mg/㎡, Q3W

Intervention Type: DRUG

Radiotherapy

Radical Radiotherapy or adjuvant Radiotherapy per guidelines.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients with T4bNanyM0 Head and neck squamous cell carcinoma (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer or oral cavity) with a confirmed diagnosis by histology and/or cytology;
• Expected survival ≥3 months, with adequate organ function;
• Investigators believe they can safely receive treatment with PD-1 combined with platinum and albumin-bound paclitaxel;
• Age ≥18 years;
• ECOG score of 0-1;
• Measurable disease as defined by RECIST v1.1;
• Adequate bone marrow reserve and organ function: Absolute neutrophil count (ANC) ≥1,000/microliter (mcL), platelets ≥75,000/mcL, hemoglobin ≥8g/dL, without transfusion or dependence on erythropoietin (EPO) (within 7 days after assessment);
• Renal function: Serum creatinine ≤1.5 times the upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥60mL/min with creatinine levels > 1.5 times the institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated according to institutional standards;
• Liver function: For subjects with a total bilirubin level >1.5 ULN, serum total bilirubin ≤1.5 times ULN or direct bilirubin ≤ULN; For patients with liver metastases, aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 times ULN OR ≤5 times ULN; Albumin > 2.5 mg/dL;
• Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, if the subject is receiving anticoagulant therapy, PT or PTT should be within the permissible range of the anticoagulant used;
• Females should agree to use contraceptive measures (such as intrauterine device (IUD), oral contraceptives, or condoms) during the study and for 6 months after the study ends; Negative serum or urine pregnancy test within 7 days before study entry, and must be non-lactating patients; Males should agree to use contraceptive measures during the study and for 6 months after the study ends.

Exclusion Criteria

• Patients with a history of prior immunotherapy, radiotherapy, and treatment with EGFR monoclonal antibodies;
• Patients with a history of other (including unknown primary) malignant tumors within the past 5 years;
• Patients who are intolerant to radiotherapy post-surgery;
• Patients known to be allergic to the study medication or its active ingredients, excipients;
• Patients with any unstable systemic diseases, including but not limited to: severe infections, uncontrolled diabetes, unstable angina, cerebrovascular accidents or transient ischemic attacks, myocardial infarction, congestive heart failure, serious arrhythmias requiring medication, liver, kidney, or metabolic disorders;
• Patients with potential immune deficiencies, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases;
• Patients with potential hematological issues, including bleeding disorders, known prior gastrointestinal bleeding requiring intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT) that is unstable on anticoagulation regimens;
• A history or any evidence of active noninfectious pneumonia;
• Known active central nervous system (CNS) metastases and/or leptomeningeal disease or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they are stable (no evidence of imaging progression for at least four weeks prior to the first trial treatment and any neurological symptoms have returned to baseline), with no new or enlarging evidence of brain metastases, and are not on steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability;
• Concurrent use (or receipt) of medications within 7 days prior to Day 1 of Cycle 1 that may affect drug metabolism;
• Pregnant or breastfeeding, or expecting to become pregnant or father a child during the anticipated trial period;
• Any uncontrollable concomitant diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias;
• Prolonged corrected QT (QTc) interval > 475 ms on screening EKG;
• Ejection fraction <40% on 2D echocardiogram (ECHO) at screening;
• Any serious medical or psychiatric illness/condition, including substance use disorders, that may interfere with or limit adherence to study requirements/treatment in the investigator's judgment;
• Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohong Chen, Dr.

Role: CONTACT

Phone: +86-10-58266699

Email: trchxh@163.com

Facility Contacts

Xiaohong Chen, Dr.

Role: primary

Other Identifiers

TREC2023-KY073

Identifier Type: -

Identifier Source: org_study_id