UnknownNot Applicable

Study of Pembrolizumab in the First Line Therapy for R/M HNSCC in China

China30 participantsStarted 2021-02-04

Plain-language summary

This trial is main evaluate the efficacy and safety of pembrolizumab in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma with PD-L1 CPS≥20.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Voluntarily sign a written informed consent before screening;
✓. Male or female, aged ≥18 years old;
✓. ECOG physical status score 0-1 points;
✓. Head and neck squamous cell carcinoma (HNSCC) confirmed by histology or cytology, the primary site is oral cavity, oropharynx, hypopharynx or larynx;
✓. Recurrent and/or metastatic HNSCC without indications for local radical treatment;
✓. According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one measurable lesion. For lesions that have received radiotherapy in the past, they can only be selected as the disease if there is a clear disease progression 3 months after the end of radiotherapy. Target lesion
✓. PD-L1 immunohistochemical detection of tumor tissue samples with CPS≥20;
✓. The expected survival period exceeds 3 months;

Exclusion criteria

✕. Patients who are suitable for local treatment and are willing to local treatment;
✕. Have received systemic chemotherapy, but does not include chemotherapy for locally advanced disease as a part of multimodal treatment (the end of this treatment must be more than 6 months from the first trial drug); Note: Multimodal treatment includes induction chemotherapy, concurrent radiotherapy and chemotherapy and adjuvant chemotherapy.
✕. Locally advanced head and neck squamous cell carcinoma multimodal treatment is completed within 6 months of disease progression;
✕. Have previously been immunized with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or drugs that target T cell co-stimulation or immune checkpoint pathways treatment;
✕. Other malignant tumors occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non-melanoma skin cancer, or other tumors/cancers that have undergone radical treatment and have no signs of disease for at least 5 years;
✕. Received cetuximab treatment within 6 months before the first administration;
✕. According to the standard of common adverse event term (NCI CTCAEv5.0), peripheral neuropathy has been ≥2 grade;
✕. Accompanied by known active central nervous system metastasis (CNS) and/or cancerous meningitis: Subjects with brain metastases who have received previous treatment can participate in the study, provided that they are clinically stable for at least 2 weeks and there are no new or expanded ones Evidence of brain metastases, and steroids were stopped 14 days before study drug administration. Stable brain metastases in this definition should be determined before the first administration of the study drug. Subjects with asymptomatic brain metastases (that is, no neurological symptoms, no corticosteroids, and no lesions\> 1.5 cm) can participate, but they need to have regular brain imaging examinations as the disease site;

What they're measuring

Objective response rate (ORR)

Timeframe: 1 year

survival time (OS)

Timeframe: 1year

Trial details

NCT IDNCT04740996

SponsorShi Yuankai

Sponsor typeUNKNOWN

Study typeOBSERVATIONAL

Primary completion2024-02

Contact for this trial

Yuankai Shi, MD

+86-10-87788293 syuankaipumc@126.com

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma trials