New cocktail shows promise for tough head and neck cancer
NCT ID NCT05673577
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tested a combination of three drugs—camrelizumab (an immunotherapy), cetuximab (a targeted therapy), and chemotherapy—as a first treatment for people with head and neck cancer that has come back or spread. The study enrolled 41 participants and measured how many had their tumors shrink or disappear. The goal is to find a more effective first-line option for this advanced cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab, cetuximab, albumin paclitaxel, cisplatin
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for patients with advanced head and neck cancer, potentially improving response rates and delaying disease progression.
- What could go wrong
- This is a small, single-center phase 2 trial with only 41 participants, so results may not apply broadly. The combination also carries risks of side effects from chemotherapy and immunotherapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
41 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fudan University
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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