Metastatic Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaozhong

About this trial

To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.

Eligibility criteria

Qualifiers

The participants voluntarily signed an informed consent form.

Age of ≥ 18 years and ≤ 75 years at the time of enrollment.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

xpected survival of ≥ 3 months.

Disqualifiers

ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.

Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.

Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.

Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance).

Trial design

Treatments tested in this trial

  • Penplimab Injection
  • Antitinib Hydrochloride Capsules
  • Gemcitabine

Treatment groups

47 Participants
are divided into 1 treatment group

Sponsors and collaborators

Chen Xiaozhong

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution