Combination treatment for advanced head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial evaluates the safety and efficacy of camrelizumab combined with cetuximab and chemotherapy in patients with relapsed or metastatic head and neck squamous cell carcinoma (HNSCC). The study aims to enroll 40 patients who have not previously received systemic chemotherapy and are not candidates for curative treatments. Participants will undergo a regimen of chemotherapy and PD-1 inhibitor therapy, with treatment cycles repeated every three weeks. The goal is to assess the effectiveness of this combination therapy as a first-line treatment option.

Why it matters

Who can join: the full rules

Main inclusion Criteria:

1. Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC.
2. Patients with distant metastases, or patients with local recurrence who are not suitable for local radical therapy, must have previously received radiotherapy (postoperative radiotherapy or radical radiotherapy) for local recurrence and must have ended radiotherapy more than 6 months ago.
3. Patients who have not received systemic chemotherapy before and who have received systemic chemotherapy as part of multidisciplinary treatment 6 months ago for locally advanced disease can be enrolled.
4. Age 18-70 years old.
5. ECOG performance status 0-1.
6. Patients must have at least one lesion that can be evaluated by enhanced CT or MRI according to Recist v1.1.
7. Hematopoietic function of bone marrow is basically normal: WBC ≥ 3.5 × 109/L, ANC ≥ 1.5 × 109/L, PLT ≥ 80 × 109/L, Hb ≥ 90 g/L.
8. Liver and kidney functions are basically normal: total bilirubin, ALT and AST are all\<1.5 × UNL (upper limit of normal value); Cr \< 1.5 × UNL, and creatinine clearance ≥ 50 ml/min.
9. Patients must have a life expectancy of at least 3 months.
10. Patients volunteered to sign informed consent.

Main exclusion Criteria:

1. Patients with a known history of severe allergy to monoclonal antibody therapy.
2. Patients with previous camrelizumab therapy or previous cetuximab therapy (cetuximab as part of therapy in multidisciplinary therapy for curative purposes may be included).
3. Patients with clinically significant heart disease, including severe cardiac insufficiency: New York College of Cardiology (NYHA) Grade IV cardiac insufficiency, unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, Q-Tc interval greater than 500ms.
4. Patients who had received secondary or higher gardes surgery within 3 weeks prior to treatment.
5. Patients suffering from autoimmune disease requiring treatment, or syndrome history requiring systemic use of steroids/immunosuppressants, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.
6. Other serious and uncontrollable concomitant diseases that may affect the compliance of the scheme or interfere with the interpretation of the results, including uncontrollable diabetes, or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history).
7. Patients have evidence of central nervous system disease.
8. Patients with known hepatitis B (HBV) (HBsAg positive and HBV DNA ≥ 103IU/ml) and hepatitis C (HCV) infection (HCV antibody positive and HCV RNA detectable); And other subjects with acquired and congenital immunodeficiency diseases, including but not limited to those infected with AIDS virus.
9. Pregnant or lactating woman.
10. Patients have serious active infection.
11. Patients have a history of serious neurological or psychiatric diseases, including dementia or epilepsy.
12. Patients may interfere with the drug abuse, medical, psychological or social conditions of the subject involved in the study or the evaluation of the study results.
13. Patients considered unsuitable by the investigator.

Where it's running

• Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Dongmei Ji, doctor — Fudan University
• Study coordinator: Dongmei Ji, Doctor
• Email: jidongmei2000@126.com
• Phone: 13564183928

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cetuximab with PD-1 therapy plus chemotherapy vs PD-1 therapy with chemotherapy for recurrent/metastatic head and neck cancer

  This trial tests whether adding cetuximab to a PD-1 inhibitor plus chemotherapy helps people with recurrent or metastatic head and neck squamous cell cancer who aren’t candidates for curative treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality and 1 other locations · NCT07509099

• Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer

  This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07063212

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies

  This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.

  Recruiting Phase 2 Renmin Hospital of Wuhan University · Wuhan, Hubei · NCT07896096

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.