Anyouping® plus Enlituo® with platinum-based chemotherapy as first-line 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 is a Phase II/III interventional study evaluating the efficacy and safety of Enlituo® combined with Anyouping® and platinum-based chemotherapy plus nab-paclitaxel as first-line treatment for advanced, recurrent, or metastatic head and neck squamous cell carcinoma. Phase II will enroll about 60 patients in a 1:1 randomization to the experimental and control arms, while Phase III will enroll about 302 patients in a double-blind, 1:1 randomization. Participants must be adults with incurable recurrent/metastatic disease and no prior systemic therapy for recurrent/metastatic disease, among other criteria. The lead sponsor is Taizhou Mabtech Pharmaceutical Co., Ltd, with the study conducted at Shanghai East Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol;
* Aged ≥ 18 years;
* Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy;
* Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant/adjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant/adjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1/PD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded.

(Remark: Subjects previously treated with PD-1/PD-L1 inhibitors may be enrolled provided a washout period of ≥ 12 months is met.)

* Have at least one measurable evaluable target lesion per RECIST v1.1, or a measurable lesion with definitive radiological progression following local therapy, and the lesion must be suitable for repeated precise measurement;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no disease deterioration within 2 weeks prior to enrollment;
* For participants with oropharyngeal carcinoma, human papillomavirus (HPV) status test results based on tumor tissue samples must be available prior to enrollment.

Exclusion Criteria:

* Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin;
* Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast cancer treated with curative resection;
* Participants with an expected survival of less than 6 months and/or rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment);
* Participants eligible for curative-intent local therapy;
* Pregnant or breastfeeding participants, or those planning pregnancy or conception during the anticipated study period (from screening visit through 180 days after the last dose);
* Known history of psychiatric disorder or substance abuse that would interfere with compliance with study requirements;
* Any other condition that renders the participant unsuitable for enrollment in the opinion of the investigator.

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zheng Zhang
• Email: zhangzheng1@zaiming.com
• Phone: +86 25-85566666

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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.