Treatment for early recurrence of head and neck cancer after surgery

A Single-arm，Single Center，Prospective，Phase II Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy for Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma

This study is testing if a new treatment combining camrelizumab with chemotherapy and radiation can help people with head and neck cancer who have had their cancer come back shortly after surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: camrelizumab, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06170697 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for patients experiencing short-term postoperative progression of head and neck squamous cell carcinoma. The study focuses on individuals who have had local or regional recurrence within six months following standard radical resection and neck lymph node dissection. By addressing the aggressive nature of this cancer type, the trial aims to improve treatment outcomes for patients who typically face poor prognoses. Participants will receive a combination of camrelizumab and various platinum-based chemotherapeutics.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have experienced local or regional recurrence of head and neck squamous cell carcinoma within six months after surgery.

Not a fit: Patients with distant metastases or those who have previously received PD-1 or PD-L1 inhibitor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with aggressive head and neck squamous cell carcinoma.

How similar studies have performed: While there have been studies on similar treatments, this specific combination approach for short-term postoperative progression is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 1.Sign written informed consent before implementing any test related processes;
* 2.Male or female subjects aged from 18 to 70 years old;
* 3.For head and neck squamous cell carcinoma after standard radical resection and neck lymph node dissection, the number of lymph node dissections is unlimited;
* 4.No neoadjuvant therapy was received before operation and no adjuvant therapy was received after operation;
* 5.Local or regional recurrence has been confirmed by at least 2 radiographs and a pathological diagnosis is not required;
* 6.The time of recurrence was less than 6 months from operation;
* 7.Whole body imaging to rule out distant metastases;
* 8.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
* 9.Adequate haematological, hepatic and renal functions defined by the protocol;
* 10.Estimated life expectancy of more than 1year;
* 11.No history of pD-1 or PD-L1 inhibitor treatment;
* 12.No underlying diseases requiring immunosuppressive therapy;
* 13.PD-L1 status is not required, but PD-L1 IHC detection is recommended;
* 14.Women of reproductive age must undergo a negative urinary pregnancy test within 7 days before starting treatment

Exclusion Criteria:

* 1.The primary site is squamous cell carcinoma of the nasopharynx or skin;
* 2.Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)；
* 3.Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
* 4.Previously received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors;
* 5.Prior organ transplantation, including allogeneic stem-cell transplantation(except corneal transplantation)；
* 6.Known history of allergy to the drug components of this regimen;
* 7.There are multiple factors (e.g. severe renal insufficiency, bone marrow suppression) that influence the chemotherapeutic agent selected by the investigator;
* 8.Before starting treatment, it has not fully recovered from the toxicity and / or complications caused by any intervention;
* 9. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, Active tuberculosis, active hepatitis B (HBV DNA \<1000 copy/ml,200 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
* 10.Accination with live or live/attenuated viruses within 4 weeks of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines;
* 11.History of uncontrolled intercurrent illness including hypertension, active infection, diabetes , hereditary bleeding , coagulopathy with a risk of bleedingor, cardiac diseases or symptoms;
* 12.Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia, and severe impaired lung function may interfere with the detection and management of suspected drug-associated pulmonary toxicity;
* 13.Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
* 14.Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;

Where this trial is running

Beijing, Beijing

• Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Jingbo Wang — Chinese academy of medical science, cancer hospital
• Study coordinator: Jingbo Wang

Conditions: Head and Neck Squamous Cell Carcinoma